The following data is part of a premarket notification filed by Taylor Corp. with the FDA for Self-contained Surgical Slush Freezer.
Device ID | K913777 |
510k Number | K913777 |
Device Name: | SELF-CONTAINED SURGICAL SLUSH FREEZER |
Classification | Freezer |
Applicant | TAYLOR CORP. 750 NORTH BLACKHAWK BLVD. Rockton, IL 61072 |
Contact | Norman L Beck |
Correspondent | Norman L Beck TAYLOR CORP. 750 NORTH BLACKHAWK BLVD. Rockton, IL 61072 |
Product Code | JRM |
CFR Regulation Number | 862.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-14 |
Decision Date | 1991-09-25 |