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 |