The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Tac' Pin.
Device ID | K993910 |
510k Number | K993910 |
Device Name: | TAC' PIN |
Classification | Pin, Fixation, Threaded |
Applicant | NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
Contact | Norman F Estrin |
Correspondent | Norman F Estrin NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-17 |
Decision Date | 2000-02-01 |
Summary: | summary |