FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYO SURG 5900
K Number: K840536
·
Decision Apr 23, 1984
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
9
Review Days
75
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Basic Information
- Device Name
- CRYO SURG 5900
- K Number
- K840536
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Frigitronics of Connecticut, Inc.
- Date Received
- February 8, 1984
- Decision Date
- April 23, 1984
- Product Code
- GEH
- 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 |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Frigitronics of Connecticut, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K891282 | MIC-100 WITH CRYOPROBES | Jun 15, 1989 | Substantially Equivalent |
| K872362 | FRIGITRONICS ACC-1000 CAPSULE CUTTER | Jul 27, 1987 | Substantially Equivalent |
| K853308 | KEATES IRRIGATION/ASPIRATION/VITREOUS CUTTER 5000 | Oct 4, 1985 | Substantially Equivalent |
| K834577 | I/A PROBE LINES | May 22, 1984 | Substantially Equivalent |
| K834437 | KEATES IRRIGATION/ASPIRATION/VITREOUS | Mar 30, 1984 | Substantially Equivalent |
| K822599 | KEATES I/A SYSTEM FRIGITRONICS 4000 | Oct 6, 1982 | Substantially Equivalent |
| K811390 | CCS100 CRYOSURGICAL SYSTEM | Jun 16, 1981 | Substantially Equivalent |
| K760742 | CS-76 AND/OR CRYOCARE I | Nov 3, 1976 | Substantially Equivalent |