The following data is part of a premarket notification filed by Dynatech Cryomedical Co. with the FDA for Dynatech Jd7/jd7p Colposcope.
Device ID | K761205 |
510k Number | K761205 |
Device Name: | DYNATECH JD7/JD7P COLPOSCOPE |
Classification | Colposcope (and Colpomicroscope) |
Applicant | DYNATECH CRYOMEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HEX |
CFR Regulation Number | 884.1630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-12-07 |
Decision Date | 1976-12-17 |