510(k) K761205
K761205 is an FDA 510(k) premarket notification submitted by Dynatech Cryomedical Co. for the device "DYNATECH JD7/JD7P COLPOSCOPE". The FDA issued a decision of Substantially Equivalent on December 17, 1976. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Dynatech Cryomedical Co. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1976
- Date Received
- December 7, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colposcope (And Colpomicroscope)
- Device Class
- Class II
- Regulation Number
- 884.1630
- Review Panel
- OB
- Submission Type