The following data is part of a premarket notification filed by General Medical Co. with the FDA for Operand* Lubricating Jelly.
| Device ID | K900110 |
| 510k Number | K900110 |
| Device Name: | OPERAND* LUBRICATING JELLY |
| Classification | Lubricant, Patient |
| Applicant | GENERAL MEDICAL CO. 1011 BOULDER SPRINGS DR., #300 Richmond, VA 23225 |
| Contact | Alfred H Grebe |
| Correspondent | Alfred H Grebe GENERAL MEDICAL CO. 1011 BOULDER SPRINGS DR., #300 Richmond, VA 23225 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-09 |
| Decision Date | 1990-05-02 |