The following data is part of a premarket notification filed by John F. Greer Co., Inc. with the FDA for Ultra-gel - #4083.
| Device ID | K864189 |
| 510k Number | K864189 |
| Device Name: | ULTRA-GEL - #4083 |
| Classification | Collector, Ostomy |
| Applicant | JOHN F. GREER CO., INC. 530 E. 12TH ST. Oakland, CA 94606 |
| Contact | Leland H Greer |
| Correspondent | Leland H Greer JOHN F. GREER CO., INC. 530 E. 12TH ST. Oakland, CA 94606 |
| Product Code | EXB |
| CFR Regulation Number | 876.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-27 |
| Decision Date | 1986-12-04 |