FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SKIN PRESSURE PROTECTORS
K Number: K761268
·
Decision Feb 16, 1977
Classifications
1
FEI Numbers
374
Registration Numbers
374
Same Product Code
22
Applicant Total
5
Review Days
62
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Basic Information
- Device Name
- SKIN PRESSURE PROTECTORS
- K Number
- K761268
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6450
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Mark One Healthcare Products
- Date Received
- December 16, 1976
- Decision Date
- February 16, 1977
- Product Code
- FMP
- 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 |
|---|---|---|---|
| FMP | Protector, Skin Pressure | FDA class 1 | General Hospital |
Similar 510(k) Clearances
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Other Clearances by Mark One Healthcare Products
| K Number | Device Name | ||
|---|---|---|---|
| K891986 | MULTIPLE-VARIOUS TYPES OF ABSORBENT INCONTINENCE | Dec 29, 1989 | Substantially Equivalent |
| K833867 | PAREMA K BAND NON-STERILE | Jan 27, 1984 | Substantially Equivalent |
| K833084 | MASTERHINGE | Oct 14, 1983 | Substantially Equivalent |
| K770396 | DRAPES, MODESTY | Mar 23, 1977 | Substantially Equivalent |