FDA 510(k)
Substantially Equivalent
🇺🇸 United States
PROTHESIS, METACARPAL
K Number: K781937
·
Decision Jan 17, 1979
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
39
Review Days
58
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Basic Information
- Device Name
- PROTHESIS, METACARPAL
- K Number
- K781937
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- November 20, 1978
- Decision Date
- January 17, 1979
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- Third Party
- N
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|---|---|---|---|
| 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 |