The following data is part of a premarket notification filed by Rocky Mountain Research, Inc. with the FDA for Els Automatic Tubing Clamp System.
Device ID | K921993 |
510k Number | K921993 |
Device Name: | ELS AUTOMATIC TUBING CLAMP SYSTEM |
Classification | Clamp, Tubing, Blood, Automatic |
Applicant | ROCKY MOUNTAIN RESEARCH, INC. 2715 EAST 3300 SOUTH Salt Lake City, UT 84109 |
Contact | Therese Davy |
Correspondent | Therese Davy ROCKY MOUNTAIN RESEARCH, INC. 2715 EAST 3300 SOUTH Salt Lake City, UT 84109 |
Product Code | FIG |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-28 |
Decision Date | 1994-01-05 |