The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Mullan Ganglion Microcompression Set.
Device ID | K940973 |
510k Number | K940973 |
Device Name: | MULLAN GANGLION MICROCOMPRESSION SET |
Classification | Instrument, Surgical, Non-powered |
Applicant | COOK, INC. 925 SOUTH CURRY PK Bloomington, IN 47403 -2624 |
Contact | April Lavender |
Correspondent | April Lavender COOK, INC. 925 SOUTH CURRY PK Bloomington, IN 47403 -2624 |
Product Code | HAO |
CFR Regulation Number | 882.4535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-03 |
Decision Date | 1995-09-29 |