The following data is part of a premarket notification filed by William W. Wilkerson & Gregory A. Knutson with the FDA for Birdie Bracket.
Device ID | K872028 |
510k Number | K872028 |
Device Name: | BIRDIE BRACKET |
Classification | Massager, Therapeutic, Electric |
Applicant | WILLIAM W. WILKERSON & GREGORY A. KNUTSON 2951 GRANADA LN. St. Paul, MN 55119 |
Product Code | ISA |
CFR Regulation Number | 890.5660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-27 |
Decision Date | 1987-07-31 |