The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Wound Dressing Kit.
Device ID | K941467 |
510k Number | K941467 |
Device Name: | WOUND DRESSING KIT |
Classification | Wrap, Sterilization |
Applicant | CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
Contact | David Insco |
Correspondent | David Insco CLINICAL RESOURCES, INC. 825A TOLLGATE RD. Elgin, IL 60123 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-28 |
Decision Date | 1994-05-12 |