The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Concept Power System.
Device ID | K881954 |
510k Number | K881954 |
Device Name: | CONCEPT POWER SYSTEM |
Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
Applicant | CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Contact | Martha C Miller |
Correspondent | Martha C Miller CONCEPT, INC. 12707 U.S. 19 SOUTH Clearwater, FL 33546 |
Product Code | HSZ |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-10 |
Decision Date | 1988-11-09 |