The following data is part of a premarket notification filed by Shur Medical Corp. with the FDA for Skin Closure Tapes Sterile.
Device ID | K790140 |
510k Number | K790140 |
Device Name: | SKIN CLOSURE TAPES STERILE |
Classification | Strip, Adhesive, Closure, Skin |
Applicant | SHUR MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-19 |
Decision Date | 1979-02-27 |