PROTECTIVE RESTRAINT


Device Classification Name

restraint, protective

510(k) Number K110377
Device Name PROTECTIVE RESTRAINT
Applicant
MEDI-TECH INTL. CORP.
26 court st., suite 1301
brooklyn, 
NY 
11242

Applicant Contact marilyn geiger
Correspondent
MEDI-TECH INTL. CORP.
26 court st., suite 1301
brooklyn, 
NY 
11242

Correspodent Contact marilyn geiger
Regulation Number 880.6760
Classification Product Code
FMQ  
Date Received 02/09/2011
Decision Date 04/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No