The following data is part of a premarket notification filed by Morrison Medical Products with the FDA for Ankle Restraint System.
Device ID | K963416 |
510k Number | K963416 |
Device Name: | ANKLE RESTRAINT SYSTEM |
Classification | Restraint, Protective |
Applicant | MORRISON MEDICAL PRODUCTS 2000 HOLLISTER DR. Libertyville, IL 60048 |
Contact | Joseph S Tokarz |
Correspondent | Joseph S Tokarz MORRISON MEDICAL PRODUCTS 2000 HOLLISTER DR. Libertyville, IL 60048 |
Product Code | FMQ |
CFR Regulation Number | 880.6760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-30 |
Decision Date | 1996-11-06 |
Summary: | summary |