The following data is part of a premarket notification filed by General Medical Co. with the FDA for Operand Lubricating Jelly.
| Device ID | K912132 |
| 510k Number | K912132 |
| Device Name: | OPERAND LUBRICATING JELLY |
| Classification | Jelly, Lubricating, For Transurethral Surgical Instrument |
| 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 | FHX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00618407002819 | K912132 | 000 |
| 00618407002802 | K912132 | 000 |
| 10884389706343 | K912132 | 000 |
| 30197344007046 | K912132 | 000 |
| 30197344007039 | K912132 | 000 |