The following data is part of a premarket notification filed by Biotex, Inc. with the FDA for Phasor Drill.
Device ID | K161704 |
510k Number | K161704 |
Device Name: | Phasor Drill |
Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
Applicant | BIOTEX, INC. 114 HOLMES RD Houston, TX 77045 |
Contact | Richard Waite |
Correspondent | Manish Ahuja BIOTEX, INC. 114 HOLMES RD Houston, TX 77045 |
Product Code | HBE |
CFR Regulation Number | 882.4310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-06-20 |
Decision Date | 2016-12-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B7755IN10 | K161704 | 000 |
B775PH2402100 | K161704 | 000 |
B775PH240210PHK20 | K161704 | 000 |
B775PH240700 | K161704 | 000 |
B775PH24070S0 | K161704 | 000 |
B775PH2702100 | K161704 | 000 |
B775PH270700 | K161704 | 000 |
B775PH27070PHK10 | K161704 | 000 |
B775PH27070PHK20 | K161704 | 000 |
B775PH27070PHKA0 | K161704 | 000 |
B775PH27070S0 | K161704 | 000 |
B775PH27070SPHKA10 | K161704 | 000 |
B775635K0 | K161704 | 000 |
B7756350 | K161704 | 000 |
B775580K0 | K161704 | 000 |
B775210L0 | K161704 | 000 |
B775240L0 | K161704 | 000 |
B775240S0 | K161704 | 000 |
B775270K0 | K161704 | 000 |
B775270L0 | K161704 | 000 |
B775270S0 | K161704 | 000 |
B775320L0 | K161704 | 000 |
B7754500 | K161704 | 000 |
B7755300 | K161704 | 000 |
B775530K0 | K161704 | 000 |
B7755800 | K161704 | 000 |
B775PH3202100 | K161704 | 000 |
B775PH45070DPHK10 | K161704 | 000 |
B775PH45070DPHKA0 | K161704 | 000 |
B775PH63570DPHKAS0 | K161704 | 000 |
B775PH63570DTPHKA1S0 | K161704 | 000 |
B775PH63570PHK10 | K161704 | 000 |
B775PH63570PHK20 | K161704 | 000 |
B775PH63570PHKA1S0 | K161704 | 000 |
B775PH63570PHKAS0 | K161704 | 000 |
B775PH635DT0 | K161704 | 000 |
M710PH2402100 | K161704 | 000 |
M710PH240700 | K161704 | 000 |
M710PH2502100 | K161704 | 000 |
M710PH2702100 | K161704 | 000 |
B775PH63570DPHKA1S0 | K161704 | 000 |
B775PH63570DPHKA0 | K161704 | 000 |
B775PH63570D0 | K161704 | 000 |
B775PH45070DPHKA10 | K161704 | 000 |
B775PH45070DT0 | K161704 | 000 |
B775PH45070DTPHKA10 | K161704 | 000 |
B775PH45070PHK10 | K161704 | 000 |
B775PH53070DPHK20 | K161704 | 000 |
B775PH53070DPHKA0 | K161704 | 000 |
B775PH53070DT0 | K161704 | 000 |
B775PH53070DTPHKA1S0 | K161704 | 000 |
B775PH580700 | K161704 | 000 |
B775PH58070D0 | K161704 | 000 |
B775PH635700 | K161704 | 000 |
M710PH270700 | K161704 | 000 |