SPYGLASS DIRECT VISULATION PROBE


Device Classification Name

endoscope and/or accessories

510(k) Number K050403
Device Name SPYGLASS DIRECT VISULATION PROBE
Applicant
BOSTON SCIENTIFIC CORP.
one boston scientific place
natick, 
MA 
01760 -1537

Applicant Contact kathleen morahan
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 02/17/2005
Decision Date 03/04/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No