The following data is part of a premarket notification filed by Sutter Corp. with the FDA for First Metatarsophalangeal Joint Motion Splint.
Device ID | K924654 |
510k Number | K924654 |
Device Name: | FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT |
Classification | Exerciser, Powered |
Applicant | SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
Contact | Louise Focht |
Correspondent | Louise Focht SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-15 |
Decision Date | 1993-02-22 |