The following data is part of a premarket notification filed by Bemis Mfg. Co. with the FDA for Sterilization Container.
Device ID | K852335 |
510k Number | K852335 |
Device Name: | STERILIZATION CONTAINER |
Classification | Wrap, Sterilization |
Applicant | BEMIS MFG. CO. 300 MILL ST. Sheboygan Falls, WI 53085 |
Contact | John B Howell |
Correspondent | John B Howell BEMIS MFG. CO. 300 MILL ST. Sheboygan Falls, WI 53085 |
Product Code | FRG |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-31 |
Decision Date | 1985-09-16 |