MYOSURE INTRUMENT TRAY


Device Classification Name

sterilization wrap containers, trays, cassettes & other accessories

510(k) Number K121280
Device Name MYOSURE INTRUMENT TRAY
Applicant
HOLOGIC, INC.
250 campus drive
marlborough, 
MA 
01752

Applicant Contact daniel f phelan
Correspondent
HOLOGIC, INC.
250 campus drive
marlborough, 
MA 
01752

Correspodent Contact daniel f phelan
Regulation Number 880.6850
Classification Product Code
KCT  
Date Received 04/30/2012
Decision Date 02/08/2013
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