The following data is part of a premarket notification filed by Pacific Hemostasis with the FDA for Pacific Hemostasis Thromboscreen 200.
Device ID | K991321 |
510k Number | K991321 |
Device Name: | PACIFIC HEMOSTASIS THROMBOSCREEN 200 |
Classification | Instrument, Coagulation |
Applicant | PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
Contact | Larry Kopyta |
Correspondent | Larry Kopyta PACIFIC HEMOSTASIS 11515 VANSTORY DR. Huntersville, NC 28078 -8144 |
Product Code | KQG |
CFR Regulation Number | 864.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-19 |
Decision Date | 1999-06-21 |
Summary: | summary |