The following data is part of a premarket notification filed by Hemodia S.a.s. with the FDA for Hemodia Arthroscopy Pump Tube Sets (hats).
Device ID | K132883 |
510k Number | K132883 |
Device Name: | HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) |
Classification | Arthroscope |
Applicant | HEMODIA S.A.S. 85 DU CHENE VERT Labege, FR 31670 |
Contact | Remi Teuliere |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2013-09-13 |
Decision Date | 2013-11-01 |
Summary: | summary |