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U.S. Department of Health and Human Services

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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beach curette no. 2 and no. 3 t.g. Pacific Dental Corp. k821789 07/06/1982
model 4815 adapter Pace Medical k002496 10/10/2000
model 4810 analyzer output adapter Pace Medical k002497 10/10/2000
pocket spirometer P.K. Morgan Instruments, Inc. k830995 04/28/1983
rlp-cholesterol immunoseparation assay Otsuka Pharmaceutical Co., Ltd. k001032 07/24/2000
osteotec silicone finger implant Osteotec, Ltd. k140453 04/17/2015
osteomed quickfix hybrid mmf sterilization tray Osteomed, LLC k173391 05/10/2018
oti ceramic femoral head system Osteoimplant Technology, Inc. k003316 01/19/2001
forearm reduction unit Orthopedic Systems, Inc. k823392 11/29/1982
avi-d control Ortho Diagnostic Systems, Inc. k811713 10/23/1981

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