The following data is part of a premarket notification filed by Minnesota Mining And Mfg. Co. with the FDA for 3m Comply 1249 Liquid Peracetic Acid Chemical Indicator.
Device ID | K000355 |
510k Number | K000355 |
Device Name: | 3M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR |
Classification | Indicator, Physical/chemical Sterilization Process |
Applicant | MINNESOTA MINING AND MFG. CO. 3M CENTER St. Paul, MN 55144 -1000 |
Contact | Gretchen Keenan |
Correspondent | Gretchen Keenan MINNESOTA MINING AND MFG. CO. 3M CENTER St. Paul, MN 55144 -1000 |
Product Code | JOJ |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-04 |
Decision Date | 2000-08-23 |