MODEL GT1ST CRYOSURGICAL INSTRUMENT
FDA 510(k) clearance K922878 · decided 1992-09-02
Clearance details
- K-number
- K922878
- Device name
- MODEL GT1ST CRYOSURGICAL INSTRUMENT
- Applicant
- Gyne-Tech Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-15
- Decision date
- 1992-09-02
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- GEH
- Device class
- 2
- Regulation number
- 878.4350
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Burbank, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.