SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR


Device Classification Name

image, illumination, fiberoptic, for endoscope

510(k) Number K991323
Device Name SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
Applicant
SMITH & NEPHEW, INC.
160 dascomb rd.
andover, 
MA 
01810

Applicant Contact deborah connors
Correspondent
SMITH & NEPHEW, INC.
160 dascomb rd.
andover, 
MA 
01810

Correspodent Contact deborah connors
Regulation Number 876.1500
Classification Product Code
FFS  
Subsequent Product Code
GCJ  
Date Received 04/19/1999
Decision Date 07/06/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized