The following data is part of a premarket notification filed by Medsurg Industries, Inc. with the FDA for Medsurg Circumcision Tray.
Device ID | K920838 |
510k Number | K920838 |
Device Name: | MEDSURG CIRCUMCISION TRAY |
Classification | Mold, Vaginal |
Applicant | MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Contact | Thomas Bonner |
Correspondent | Thomas Bonner MEDSURG INDUSTRIES, INC. 251 EXCHANGE PLACE Herndon, VA 20170 -4822 |
Product Code | HFK |
CFR Regulation Number | 884.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-24 |
Decision Date | 1993-10-15 |