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