FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
K Number: K962288
·
Decision Jan 30, 1997
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
14
Applicant Total
1
Review Days
230
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
- COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER
- K Number
- K962288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pinnacle Products, Inc.
- Date Received
- June 14, 1996
- Decision Date
- January 30, 1997
- Product Code
- MMP
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| MMP | Cover, Barrier, Protective | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MMP), ordered by most recent decision date.
MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LIGHT DRAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INCUBATOR CAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDLINE BAND BAGS AND EQUIPMENT COVERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09
FDA 510(k)
FDA Class 2
·General, Plastic Surgery