The following data is part of a premarket notification filed by Quick-med Technologies, Inc. with the FDA for Stay Fresh Skin Fold Management Textile.
Device ID | K121898 |
510k Number | K121898 |
Device Name: | STAY FRESH SKIN FOLD MANAGEMENT TEXTILE |
Classification | Fiber, Medical, Absorbent |
Applicant | QUICK-MED TECHNOLOGIES, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
Contact | Mary Mcnamara-cullinane |
Correspondent | Mary Mcnamara-cullinane QUICK-MED TECHNOLOGIES, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
Product Code | FRL |
CFR Regulation Number | 880.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-29 |
Decision Date | 2013-05-24 |
Summary: | summary |