The following data is part of a premarket notification filed by Deka Research & Development Corp. with the FDA for Deka Tac Device.
Device ID | K093915 |
510k Number | K093915 |
Device Name: | DEKA TAC DEVICE |
Classification | Clamp, Tubing, Blood, Automatic |
Applicant | DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 -1108 |
Contact | Robert Swain |
Correspondent | Robert Swain DEKA RESEARCH & DEVELOPMENT CORP. 340 COMMERCIAL ST. Manchester, NH 03101 -1108 |
Product Code | FIG |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-12-22 |
Decision Date | 2011-08-23 |
Summary: | summary |