The following data is part of a premarket notification filed by Minnesota Scientific, Inc. with the FDA for Omni-tract Corral Retractor.
Device ID | K872919 |
510k Number | K872919 |
Device Name: | OMNI-TRACT CORRAL RETRACTOR |
Classification | Retractor |
Applicant | MINNESOTA SCIENTIFIC, INC. 3839 CHANDLER DR. Minneapolis, MN 55421 |
Contact | Bruce A Levahn |
Correspondent | Bruce A Levahn MINNESOTA SCIENTIFIC, INC. 3839 CHANDLER DR. Minneapolis, MN 55421 |
Product Code | GAD |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-27 |
Decision Date | 1987-08-11 |