OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP


Device Classification Name

powered laser surgical instrument

510(k) Number K992230
Device Name OMNITIP SIDE FIRING SWITCHABLE TIP WITH SUCTION/IRRIGATION, MODEL 20371-HP
Applicant
TRIMEDYNE, INC.
2801 barranca rd.
p.o. box 57001
irvine, 
CA 
92619 -7001

Applicant Contact susan h gamble
Correspondent
TRIMEDYNE, INC.
2801 barranca rd.
p.o. box 57001
irvine, 
CA 
92619 -7001

Correspodent Contact susan h gamble
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Codes
GBX   GCX  
Date Received 07/02/1999
Decision Date 07/12/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No