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 |