The following data is part of a premarket notification filed by Medical Accessories, Inc. with the FDA for Redyplate Disposable Leg Plate.
Device ID | K901152 |
510k Number | K901152 |
Device Name: | REDYPLATE DISPOSABLE LEG PLATE |
Classification | Electrode, Circular (spiral), Scalp And Applicator |
Applicant | MEDICAL ACCESSORIES, INC. 92 YOUNGS RD. Trenton, NJ 08619 |
Contact | G Ziedonis |
Correspondent | G Ziedonis MEDICAL ACCESSORIES, INC. 92 YOUNGS RD. Trenton, NJ 08619 |
Product Code | HGP |
CFR Regulation Number | 884.2675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-13 |
Decision Date | 1990-04-04 |