The following data is part of a premarket notification filed by Progressive Concepts, Inc. with the FDA for Versatell; Versatell-s.
Device ID | K941959 |
510k Number | K941959 |
Device Name: | VERSATELL; VERSATELL-S |
Classification | Device, Biofeedback |
Applicant | PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
Contact | Ray Fischer |
Correspondent | Ray Fischer PROGRESSIVE CONCEPTS, INC. 22194 HILLSBORO RD. Denton, MD 21629 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-22 |
Decision Date | 1995-06-21 |