The following data is part of a premarket notification filed by Medcare Custom Packaging, Inc. with the FDA for Towel Pack.
| Device ID | K952759 |
| 510k Number | K952759 |
| Device Name: | TOWEL PACK |
| Classification | Drape, Surgical |
| Applicant | MEDCARE CUSTOM PACKAGING, INC. 234 OLD HOMESTEAD HIGHWAY ROUTE 32 East Swanzey, NH 03446 |
| Contact | William A Hays |
| Correspondent | William A Hays MEDCARE CUSTOM PACKAGING, INC. 234 OLD HOMESTEAD HIGHWAY ROUTE 32 East Swanzey, NH 03446 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-16 |
| Decision Date | 1995-09-29 |