FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIN SAVER SYSTEMS
K Number: K952738
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
681
Registration Numbers
681
Same Product Code
41
Applicant Total
1
Review Days
107
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SKIN SAVER SYSTEMS
- K Number
- K952738
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5075
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Skin Saver Systems, Inc.
- Date Received
- June 14, 1995
- Decision Date
- September 29, 1995
- Product Code
- FQM
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FQM | Bandage, Elastic | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FQM), ordered by most recent decision date.
PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDE
FDA 510(k)
FDA Class 1
·General Hospital
BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLE
FDA 510(k)
FDA Class 1
·General Hospital
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBE
FDA 510(k)
FDA Class 1
·General Hospital
ASPEN ESMARK BANDAGE
FDA 510(k)
FDA Class 1
·General Hospital
TUBE-BANDAGE FOR HUMAN DIGITS 200
FDA 510(k)
FDA Class 1
·General Hospital
MEDICALEX
FDA 510(k)
FDA Class 1
·General Hospital