The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Chemical Autoclave Indicator Tape.
Device ID | K811936 |
510k Number | K811936 |
Device Name: | CHEMICAL AUTOCLAVE INDICATOR TAPE |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-06 |
Decision Date | 1981-07-28 |