The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Additional Hemotec Act Coagulation Cartridges.
Device ID | K853198 |
510k Number | K853198 |
Device Name: | ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
Applicant | MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
Contact | William A Morton |
Correspondent | William A Morton MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
Product Code | JPA |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-30 |
Decision Date | 1985-10-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20643169577484 | K853198 | 000 |
20613994531821 | K853198 | 000 |
20613994417286 | K853198 | 000 |
00763000433833 | K853198 | 000 |