The following data is part of a premarket notification filed by Epcom Medical Systems, Inc. with the FDA for Glove-n-gel Amniotomy Kit.
| Device ID | K910518 |
| 510k Number | K910518 |
| Device Name: | GLOVE-N-GEL AMNIOTOMY KIT |
| Classification | Amniotome |
| Applicant | EPCOM MEDICAL SYSTEMS, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Contact | Paul Ulbrich |
| Correspondent | Paul Ulbrich EPCOM MEDICAL SYSTEMS, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Product Code | HGE |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-06 |
| Decision Date | 1991-05-09 |