510(k) K083476
- Device
- NOVEON MODEL LS1100-03
- Applicant
- Nomir Medical Technologies, Inc.
- 510(k) number
- K083476
- Product code
- GEX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-12-22
- Date received
- 2008-11-24
- Regulation
- 878.4810
- Classification name
- Powered Laser Surgical Instrument
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD F BURTT
- Address
- 307 Waverley Oaks Rd. Suite 109 Waltham MA US 02452 02452
FDA Registration Numbers#
- 3022327202
- 3007731000
- 3009970070
- 3006427656
- 3043047259
- 3007549439
- 3007689716
- 3012799115
- 3004135191
- 3014226003
- 2011171
- 3004505220
- 3030979014
- 3003708273
- 3038715747
- 3015392301
- 1018233
- 3039080630
- 3011050570
- 3016181563
- 3025379728
- 3006985208
- 3037874486
- 3033524191
- 3026038437
- 3037047060
- 3031944951
- 3005238200
- 3004635398
- 3033126947
- 3030420005
- 3048506982
- 3033482500
- 3032147807
- 2031934
- 3004111573
- 3010627091
- 3015807001
- 1000548922
- 3021550489
- 3009746061
- 3012125201
- 3006368133
- 3012104022
- 3002736133
- 3030230686
- 8040564
- 1424263
- 3015262665
- 3015151147
- 3006515340
- 3015167792
- 3003082988
- 3008872264
- 3007120647
- 3007674911
- 3014225468
- 3034246188
- 2183911
- 3043127589
- 1226005
- 3038197172
- 3009649442
- 3013404959
- 1644312
- 3011670002
- 3006716777
- 3011423170
- 3021334828
- 3002808227
- 3014253920
- 3023816720
- 3008252121
- 3016496662
- 3008925277
- 3034630389
- 3030543531
- 3006247712
- 9681260
Source Documents#
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