The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Anaerobic Transport Pouch (catalyst-free).
| Device ID | K871709 |
| 510k Number | K871709 |
| Device Name: | ANAEROBIC TRANSPORT POUCH (CATALYST-FREE) |
| Classification | Device, Gas Generating |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | Walter S Fisher |
| Correspondent | Walter S Fisher DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | KZJ |
| CFR Regulation Number | 866.2580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-01 |
| Decision Date | 1987-05-15 |