510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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|---|---|---|---|
| synthes proximal humeral nail | SYNTHES (USA) | k002729 |
10/06/2000 |
| synthes anterior cslp system | SYNTHES SPINE | k000742 |
03/29/2000 |
| swissplus implant system, model spwb 8,10,12,14/oph20/smpr, spb 8,10,12,14/op3.5d/opar,opb 8,10,12,14/op2.3d/op2.8d, | CORE-VENT CORP. | k002188 |
10/30/2000 |
| swabsite swabbable valve, model 245000 | QUEST MEDICAL, INC. | k002689 |
03/06/2001 |
| surgical contra-angel handpieces types ws-56e,ws-75e/km,ws-92 e/3,surgical straight handpieces types, s-9, s-10, s-11 | W & H DENTALWERK BUERMOOS GMBH | k011061 |
06/28/2001 |
| super nova, acubeam | LIGHT FORCE THERAPY, INC. | k001179 |
10/27/2000 |
| summit occipito-cervico-thoracic (oct) spinal system | DEPUY ACROMED | k002733 |
12/15/2000 |
| summit cemented hip prosthesis | DEPUY ORTHOPAEDICS, INC. | k013352 |
12/17/2001 |
| stryker navigation system - ent module | STRYKER CORP. | k002732 |
10/02/2000 |
| steritec autoclave tapes, model ci122 & ci1234 | STERITEC PRODUCTS, INC. | k001649 |
06/23/2000 |
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