The following data is part of a premarket notification filed by Iogyn, Inc. with the FDA for Iogyn Endoscope.
Device ID | K123330 |
510k Number | K123330 |
Device Name: | IOGYN ENDOSCOPE |
Classification | Hysteroscope (and Accessories) |
Applicant | IOGYN, INC. 5353 WAYZATA BOULEVARD STE. 505 Minneapolis, MN 55416 |
Contact | Mary J Edwards |
Correspondent | Mary J Edwards IOGYN, INC. 5353 WAYZATA BOULEVARD STE. 505 Minneapolis, MN 55416 |
Product Code | HIH |
CFR Regulation Number | 884.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-26 |
Decision Date | 2013-03-19 |
Summary: | summary |