FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ARMBOARD CVER, DISPOSABLE
K Number: K782092
·
Decision Jan 10, 1979
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
12
Applicant Total
44
Review Days
27
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Basic Information
- Device Name
- ARMBOARD CVER, DISPOSABLE
- K Number
- K782092
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4950
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Anago, Inc.
- Date Received
- December 14, 1978
- Decision Date
- January 10, 1979
- Product Code
- FSE
- 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 |
|---|---|---|---|
| FSE | Table, Operating-Room, Manual | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSE), ordered by most recent decision date.
THE POREX RETRACTOR TABLE
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SELF-CONTAINED MOBILE OPHTHAL. OPER. .
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Other Clearances by Anago, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K925659 | U.C.E.Z. LENS CLEANER KIT | Sep 17, 1993 | Substantially Equivalent |
| K930161 | ANAGO SPINAL ANESTHESIA TRAY | Jul 6, 1993 | Unknown |
| K926589 | ANAGO WARM PACK | May 26, 1993 | Substantially Equivalent |
| K926590 | ANAGO DISPOSABLE INSTANT COLD PACK | May 26, 1993 | Substantially Equivalent |
| K926137 | ANAGO FEM-COOL/FEM-COOL PETITE | May 26, 1993 | Substantially Equivalent |
| K920615 | ANAGO CONTINUOUS EPIDURAL ANESTHESIA TRAY/KIT | Mar 20, 1993 | Unknown |
| K915415 | GUARDALL SHIELD | Oct 15, 1992 | Substantially Equivalent |
| K913558 | RELIABLE CONE STYLE FACE MASK | Nov 7, 1991 | Substantially Equivalent |
| K905865 | ANTI-FOR SURGICAL FACE MASK | Mar 6, 1991 | Substantially Equivalent |
| K905749 | SURGICAL FACE MASK | Mar 4, 1991 | Substantially Equivalent |