The following data is part of a premarket notification filed by Kinetikos Medical, Inc. with the FDA for Diao Hand Surgery Set.
Device ID | K960539 |
510k Number | K960539 |
Device Name: | DIAO HAND SURGERY SET |
Classification | Probe |
Applicant | KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
Contact | Mark G Urbanski |
Correspondent | Mark G Urbanski KINETIKOS MEDICAL, INC. 3950 SORRENTO VALLEY BLVD., San Diego, CA 92121 |
Product Code | HXB |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-07 |
Decision Date | 1996-07-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DIAO HAND SURGERY SET 75120415 not registered Dead/Abandoned |
Kinetikos Medical, Inc. 1996-06-17 |