510(k) K091107
- Device
- MODEL P8400 HEMOSTATIX THERMAL SCALPEL SYSTEM
- Applicant
- HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
- 510(k) number
- K091107
- Product code
- GEI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-05-01
- Date received
- 2009-04-16
- Regulation
- 878.4400
- Classification name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- JEFF COBB
- Address
- 8400 Wolf Lake Dr., Suite 109 Bartlett TN US 38133 38133
FDA Registration Numbers#
- 3013376016
- 3009217531
- 3006561161
- 3027339877
- 3005064943
- 9611503
- 3006639944
- 8010312
- 1721504
- 3003687489
- 2087572
- 3012995405
- 1320894
- 3008843439
- 1222780
- 8030967
- 3015153469
- 3014479313
- 3007593903
- 3006807694
- 2183785
- 3012616488
- 3026606306
- 2433012
- 1221934
- 3014656892
- 3005528784
- 3008747667
- 3009763019
- 3011050570
- 9680660
- 3027242374
- 3012447612
- 3004361445
- 3007748817
- 3031916226
- 3013602304
- 3002808022
- 3015976667
- 2528981
- 3014980461
- 3015895045
- 3016087306
- 3015531529
- 3011120183
- 3008849319
- 3002806603
- 3015460875
- 3010739934
- 3020163307
- 3010132111
- 2219920
- 9613793
- 3029916132
- 3011221476
- 3015449142
- 3004044817
- 3018094310
- 9680952
- 1043214
- 3010601992
- 3009051888
- 3012263546
- 1061927
- 3032109
- 3007867778
- 3010805941
- 3016020790
- 3020968442
- 3048141561
- 3006638824
- 8040510
- 3003542872
- 3010493171
- 3011683674
- 3011989678
- 3012259264
- 1225492
- 3010188783
Source Documents#
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Legacy Summary#
summary
FDA Review#
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