The following data is part of a premarket notification filed by Clinical Resources, Inc. with the FDA for Suture Removal Kit.
Device ID | K941465 |
510k Number | K941465 |
Device Name: | SUTURE REMOVAL KIT |
Classification | Suture Removal Kit |
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 | MCZ |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-28 |
Decision Date | 1994-04-22 |