The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Aloft Sterilization Wrap.
Device ID | K803306 |
510k Number | K803306 |
Device Name: | ALOFT STERILIZATION WRAP |
Classification | Wrap, Sterilization |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-12-30 |
Decision Date | 1981-02-05 |