FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GAMMA RADIATION STERILIZATION PRECEDURE
K Number: K781668
·
Decision Nov 3, 1978
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
13
Applicant Total
39
Review Days
36
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Basic Information
- Device Name
- GAMMA RADIATION STERILIZATION PRECEDURE
- K Number
- K781668
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3230
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- September 28, 1978
- Decision Date
- November 3, 1978
- Product Code
- KYJ
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| KYJ | Prosthesis, Finger, Constrained, Polymer | FDA class 2 | Orthopedic |
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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 |