The following data is part of a premarket notification filed by Cohort Medical Products Group, Inc. with the FDA for Cohort Avb Retractor System.
Device ID | K943472 |
510k Number | K943472 |
Device Name: | COHORT AVB RETRACTOR SYSTEM |
Classification | Probe |
Applicant | COHORT MEDICAL PRODUCTS GROUP, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
Contact | Mark Urbanski |
Correspondent | Mark Urbanski COHORT MEDICAL PRODUCTS GROUP, INC. 25590 SEABOARD LN. Hayward, CA 94545 |
Product Code | HXB |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-19 |
Decision Date | 1994-10-20 |