The following data is part of a premarket notification filed by Progressive Concepts, Inc. with the FDA for Biostim-hv.
Device ID | K946298 |
510k Number | K946298 |
Device Name: | BIOSTIM-HV |
Classification | Stimulator, Muscle, Powered |
Applicant | PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
Contact | W R Fischer |
Correspondent | W R Fischer PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-27 |
Decision Date | 1995-05-11 |