The following data is part of a premarket notification filed by Cutting Edge Technologies, Inc. with the FDA for Targett Patch.
Device ID | K952606 |
510k Number | K952606 |
Device Name: | TARGETT PATCH |
Classification | Tape And Bandage, Adhesive |
Applicant | CUTTING EDGE TECHNOLOGIES, INC. 11 ROSELAWN LN. Malvern, PA 19355 |
Contact | George H Myers |
Correspondent | George H Myers CUTTING EDGE TECHNOLOGIES, INC. 11 ROSELAWN LN. Malvern, PA 19355 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-06 |
Decision Date | 1995-12-21 |