Quality and Relationship You Can Trust

Glossary



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510(k)   This abbreviation stands for section 510(k) of the Federal Food, Drug and Cosmetic Act which states that a person who intends to introduce a devise into commercial distribution in the United States is required to submit a premarket notification, popularly called the 510(k), to the FDA at least 90 days before commercial distribution is to begin. A manufacturer shall be issued a letter of substantial equivalence and carry a unique 510(k) number to enable him to commence commercial distribution of the device applied. 510(k) is not a quality program and shall not be confused with ISO, GMP or ASTM.
     

Contact Information

Rubbercare Protection Products Sdn Bhd (169997-P)
Office:
Lot 120&121, Jalan Senawang 3,
Senawang Industrial Estate,
70450 Seremban,
Negeri Sembilan Darul Khusus, Malaysia.

Factory:
Lot 110, Lorong Senawang 4/3,
Off Jalan Senawang Empat,
Senawang Industrial Estate,
70450 Seremban,
Negeri Sembilan Darul Khusus, Malaysia.

Tel: +60 6 677 2781
Fax: +60 6 677 2780
Emails:
careplus@po.jaring.my (Marketing)
info@careplus.com (Enquiries)