The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Sterilization Indicator For Flash Sterilization.
Device ID | K871672 |
510k Number | K871672 |
Device Name: | STERILIZATION INDICATOR FOR FLASH STERILIZATION |
Classification | Indicator, Sterilization |
Applicant | PROPPER MFG. CO., INC. 3604 SKILLMAN AVE. Long Island City, NY 11101 |
Contact | Augurt, Phd |
Correspondent | Augurt, Phd PROPPER MFG. CO., INC. 3604 SKILLMAN AVE. Long Island City, NY 11101 |
Product Code | LRT |
CFR Regulation Number | 880.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-28 |
Decision Date | 1987-06-01 |