The following data is part of a premarket notification filed by O'tec Corp. with the FDA for Knowles Pin.
Device ID | K905344 |
510k Number | K905344 |
Device Name: | KNOWLES PIN |
Classification | Pin, Fixation, Threaded |
Applicant | O'TEC CORP. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
Contact | Ricardo Heros |
Correspondent | Ricardo Heros O'TEC CORP. 6685 QUINCE SUITE 106 Memphis, TN 38119 |
Product Code | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-28 |
Decision Date | 1990-12-11 |