The following data is part of a premarket notification filed by Bradstreet Clinical Research Assoc., Inc. with the FDA for Flutter(r).
| Device ID | K946083 |
| 510k Number | K946083 |
| Device Name: | FLUTTER(R) |
| Classification | Percussor, Powered-electric |
| Applicant | BRADSTREET CLINICAL RESEARCH ASSOC., INC. 1588 ROUTE 130 NORTH SUITE C-2 North Brunswick, NJ 08902 |
| Contact | Patricia W Bradstreet |
| Correspondent | Patricia W Bradstreet BRADSTREET CLINICAL RESEARCH ASSOC., INC. 1588 ROUTE 130 NORTH SUITE C-2 North Brunswick, NJ 08902 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-13 |
| Decision Date | 1995-03-13 |