The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Eagle Pac/visible Seal.
Device ID | K781699 |
510k Number | K781699 |
Device Name: | EAGLE PAC/VISIBLE SEAL |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | AMERICAN STERILIZER CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-11 |
Decision Date | 1978-10-24 |