FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGICAL RETRACTOR
K Number: K760422
·
Decision Aug 23, 1976
Classifications
1
FEI Numbers
656
Registration Numbers
656
Same Product Code
99
Applicant Total
39
Review Days
13
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Basic Information
- Device Name
- SURGICAL RETRACTOR
- K Number
- K760422
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- August 10, 1976
- Decision Date
- August 23, 1976
- Product Code
- GAD
- 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 |
|---|---|---|---|
| GAD | Retractor | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Cutter Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861315 | HYPERBARIC PENETRATION EXTENSION SET | May 21, 1986 | Substantially Equivalent |
| K854106 | BAYSILEX | Mar 17, 1986 | Substantially Equivalent |
| K842324 | PERFOURM | Nov 9, 1984 | Substantially Equivalent |
| K834106 | INTRAVENOUS INFUSION CONTROLLER | May 30, 1984 | Substantially Equivalent |
| K832237 | ORTHOPEDIC CASTING TAPE MAXCAST | Aug 16, 1983 | Substantially Equivalent |
| K823214 | DOSIMETRIC RELEASE PROGRAM - ADMIN. SET | Jan 12, 1983 | Substantially Equivalent |
| K821326 | CUTTER BOND POLYCARBOXYLATE CEMENT | May 28, 1982 | Substantially Equivalent |
| K813532 | CUTTERBOND ZINC PHOSPHATE CEMENT | Mar 2, 1982 | Substantially Equivalent |
| K802105 | C-BLADE | Sep 16, 1980 | Substantially Equivalent |
| K802104 | C-SPLINT | Sep 16, 1980 | Substantially Equivalent |