The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for A.t.s. 1500 Tourniquet.
Device ID | K870784 |
510k Number | K870784 |
Device Name: | A.T.S. 1500 TOURNIQUET |
Classification | Tourniquet, Pneumatic |
Applicant | ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
Contact | Johnson |
Correspondent | Johnson ASPEN LABORATORIES, INC. P.O. BOX 3936 Englewood, CO 80155 -3936 |
Product Code | KCY |
CFR Regulation Number | 878.5910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-26 |
Decision Date | 1987-03-18 |