The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Thora-drain(r) Abt System.
Device ID | K871624 |
510k Number | K871624 |
Device Name: | THORA-DRAIN(R) ABT SYSTEM |
Classification | Apparatus, Autotransfusion |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | Mccarley |
Correspondent | Mccarley SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Product Code | CAC |
CFR Regulation Number | 868.5830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-27 |
Decision Date | 1987-06-22 |