The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Blue Seal Ii Sterilization Pouch.
| Device ID | K851340 |
| 510k Number | K851340 |
| Device Name: | BLUE SEAL II STERILIZATION POUCH |
| Classification | Wrap, Sterilization |
| Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Contact | James A Spallina |
| Correspondent | James A Spallina AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-03 |
| Decision Date | 1985-04-24 |