The following data is part of a premarket notification filed by Bryan Corp. with the FDA for Baggish, Hysteroscope.
Device ID | K881249 |
510k Number | K881249 |
Device Name: | BAGGISH, HYSTEROSCOPE |
Classification | Hysteroscope (and Accessories) |
Applicant | BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
Contact | Frank M Abrano |
Correspondent | Frank M Abrano BRYAN CORP. FOUR PLYMPTON ST. Woburn, MA 01801 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-23 |
Decision Date | 1988-07-28 |