The following data is part of a premarket notification filed by Global Protection Corp. with the FDA for Knight Light Nonlubricated Condom.
Device ID | K960552 |
510k Number | K960552 |
Device Name: | KNIGHT LIGHT NONLUBRICATED CONDOM |
Classification | Condom |
Applicant | GLOBAL PROTECTION CORP. 116 VILLAGE BLVD. SUITE 200 Princeton, NJ 08540 -5799 |
Contact | Thomas Becze |
Correspondent | Thomas Becze GLOBAL PROTECTION CORP. 116 VILLAGE BLVD. SUITE 200 Princeton, NJ 08540 -5799 |
Product Code | HIS |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-08 |
Decision Date | 1997-11-20 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850002174700 | K960552 | 000 |
00850002174649 | K960552 | 000 |