FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFOURM
K Number: K842324
·
Decision Nov 9, 1984
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
39
Review Days
149
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Basic Information
- Device Name
- PERFOURM
- K Number
- K842324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Cutter Laboratories, Inc.
- Date Received
- June 13, 1984
- Decision Date
- November 9, 1984
- Product Code
- ELW
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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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 |
| 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 |
| K801652 | TOTAL PARENTERAL NUTRITION SET BAG | Aug 27, 1980 | Substantially Equivalent |