The following data is part of a premarket notification filed by Dynatech Cryomedical Co. with the FDA for Colposcope (dynatech Colposcope-model I.
Device ID | K760763 |
510k Number | K760763 |
Device Name: | COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I |
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 | 1976-10-04 |
Decision Date | 1976-10-20 |