INTEGRA LED SURGICAL HEADLIGHT SYSTEM


Device Classification Name

light, headband, surgical

510(k) Number K110528
Device Name INTEGRA LED SURGICAL HEADLIGHT SYSTEM
Applicant
INTEGRA LIFE SCIENCES CORPORATION
589 davies drive
york, 
PA 
17402

Applicant Contact stephanie sheesley
Correspondent
INTEGRA LIFE SCIENCES CORPORATION
589 davies drive
york, 
PA 
17402

Correspodent Contact stephanie sheesley
Regulation Number 886.4335
Classification Product Code
FSR  
Date Received 02/24/2011
Decision Date 05/11/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No