FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES
K Number: K935356
·
Decision Mar 23, 1994
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
5
Applicant Total
1
Review Days
139
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
- CAPTAIN'S CHAIR ACCESSORY TO AMSCO SURGICAL TABLES
- K Number
- K935356
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Amsco American Sterilizer Co.
- Date Received
- November 4, 1993
- Decision Date
- March 23, 1994
- Product Code
- FWW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| FWW | Table, Operating-Room, Pneumatic | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FWW), ordered by most recent decision date.
OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FISK ARM SUPPORT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
UNIVERSAL SURGICAL INSTRUMENT HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TABLE, OPERATING ROOM, HYDRAULIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SKYTRON ELITE 300 SURGERY TABLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery