The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Micromill.
Device ID | K912957 |
510k Number | K912957 |
Device Name: | CONCEPT MICROMILL |
Classification | Arthroscope |
Applicant | CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
Contact | Martha Miller |
Correspondent | Martha Miller CONCEPT, INC. 11311 CONCEPT BLVD. Largo, FL 34643 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-08 |
Decision Date | 1991-10-04 |