The following data is part of a premarket notification filed by Propper Mfg. Co., Inc. with the FDA for Propper Sharpguard & Traypad Steril. Aid.
Device ID | K802428 |
510k Number | K802428 |
Device Name: | PROPPER SHARPGUARD & TRAYPAD STERIL. AID |
Classification | Wrap, Sterilization |
Applicant | PROPPER MFG. CO., INC. 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 | 1980-10-06 |
Decision Date | 1980-10-23 |