The following data is part of a premarket notification filed by E.m. Adams with the FDA for Autoclave Pouches&rolls/steam&gas.
Device ID | K780034 |
510k Number | K780034 |
Device Name: | AUTOCLAVE POUCHES&ROLLS/STEAM&GAS |
Classification | Wrap, Sterilization |
Applicant | E.M. ADAMS 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 | 1978-01-09 |
Decision Date | 1978-02-21 |