The following data is part of a premarket notification filed by Rynel Ltd, Inc. with the FDA for Rynel Medical Foam.
| Device ID | K951909 |
| 510k Number | K951909 |
| Device Name: | RYNEL MEDICAL FOAM |
| Classification | Bandage, Liquid |
| Applicant | RYNEL LTD, INC. ROUTE 27 Boothbay, ME 04537 |
| Contact | Tim Thomson |
| Correspondent | Tim Thomson RYNEL LTD, INC. ROUTE 27 Boothbay, ME 04537 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-24 |
| Decision Date | 1995-06-21 |