The following data is part of a premarket notification filed by Skin Saver Systems, Inc. with the FDA for Skin Saver Systems.
| Device ID | K952738 |
| 510k Number | K952738 |
| Device Name: | SKIN SAVER SYSTEMS |
| Classification | Bandage, Elastic |
| Applicant | SKIN SAVER SYSTEMS, INC. 18158 EAST LONG AVE. Aurora, CO 80016 |
| Contact | Barry F Shesol |
| Correspondent | Barry F Shesol SKIN SAVER SYSTEMS, INC. 18158 EAST LONG AVE. Aurora, CO 80016 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-14 |
| Decision Date | 1995-09-29 |