The following data is part of a premarket notification filed by Ortho Pharmaceutical Corp. with the FDA for K-y Personal Lubricant.
| Device ID | K955648 |
| 510k Number | K955648 |
| Device Name: | K-Y PERSONAL LUBRICANT |
| Classification | Condom |
| Applicant | ORTHO PHARMACEUTICAL CORP. RT. 202 Raritan, NJ 08869 -0602 |
| Contact | Diane Herron |
| Correspondent | Diane Herron ORTHO PHARMACEUTICAL CORP. RT. 202 Raritan, NJ 08869 -0602 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-12 |
| Decision Date | 1996-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20067981089268 | K955648 | 000 |
| 20067981087080 | K955648 | 000 |
| 20067981087905 | K955648 | 000 |