The following data is part of a premarket notification filed by General Medical Co. with the FDA for Operand Lubricating Jelly.
| Device ID | K912975 |
| 510k Number | K912975 |
| Device Name: | OPERAND LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | GENERAL MEDICAL CO. P.O. BOX 237 PRICHARD INDUSTRIAL PARK Prichard, WV 25555 |
| Contact | Richard J.marshall |
| Correspondent | Richard J.marshall GENERAL MEDICAL CO. P.O. BOX 237 PRICHARD INDUSTRIAL PARK Prichard, WV 25555 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1991-09-27 |