510(k) K935034
- Device
- Laser Gas Mixture
- Applicant
- TRI-GAS, INC.
- 510(k) number
- K935034
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-12-14
- Date received
- 1993-06-14
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GERALD SMITH
- Address
- 2200 Houston Ave. Houston TX US 77007 77007
FDA Registration Numbers#
- 3006985163
- 3007731000
- 3010027944
- 3044175602
- 2938071
- 3017125161
- 3001222017
- 3003708273
- 3009380063
- 3006985208
- 3012452798
- 3010822033
- 3042261306
- 3016076698
- 2134812
- 3013121972
- 2011068
- 3007712511
- 3011137372
- 3034246188
- 3009462521
- 3011670002
- 3017144492
- 3004450661
- 1032227
- 3007085226
- 3033715699
- 3013404959
- 3012294783
- 1045254
- 9611388
- 3045892905
- 3008776882
- 3015392301
- 3014310779
- 1221543
- 3015452693
- 3044905918
- 3012669557
- 2032513
- 3026360847
- 8030392
- 3006546082
- 1820334
- 3017060146
- 3009241253
- 3025379728
- 3031944951
- 3011423170
- 3003899230
- 3004361445
- 3009453258
- 3012133441
- 3026668625
- 8040564
- 3014577013
- 3043012240
- 3004710757
- 3017124433
- 3023816720
- 3035375056
- 3011024620
- 3010902869
- 3008627763
- 3017140525
- 3005791808
- 3004111573
- 3003542872
- 9616684
- 2011171
- 3020756
- 8043792
- 3002736133
- 3002807636
- 2953696
- 3009488834
- 3022327202
- 3026294985
- 3012322232
Source Documents#
510(k) summary PDF not indicated by FDA
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