The following data is part of a premarket notification filed by Peter Stevens, Md with the FDA for 5.0 Cannulated Drill Pin, 6.0 Cannulated Drill-pin.
Device ID | K033856 |
510k Number | K033856 |
Device Name: | 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | PETER STEVENS, MD PO BOX 58246 Salt Lake City, UT 84158 |
Contact | Peter Stevens, Md |
Correspondent | Peter Stevens, Md PETER STEVENS, MD PO BOX 58246 Salt Lake City, UT 84158 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-12-11 |
Decision Date | 2005-01-07 |