The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Hewson A.c.l. Guide Set.
Device ID | K872608 |
510k Number | K872608 |
Device Name: | HEWSON A.C.L. GUIDE SET |
Classification | Retention Device, Suture |
Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Contact | Penny Rasmussen |
Correspondent | Penny Rasmussen CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Product Code | KGS |
CFR Regulation Number | 878.4930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-06 |
Decision Date | 1987-09-16 |