The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Threaded Fixation Pin.
Device ID | K982931 |
510k Number | K982931 |
Device Name: | THREADED FIXATION PIN |
Classification | Pin, Fixation, Threaded |
Applicant | SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos, CA 95030 |
Contact | Thomas Sgarlato |
Correspondent | Thomas Sgarlato SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos, CA 95030 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-20 |
Decision Date | 1998-10-21 |
Summary: | summary |