The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Biosphere Anaerobic Environmental Device.
Device ID | K862123 |
510k Number | K862123 |
Device Name: | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE |
Classification | Device, Gas Generating |
Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
Contact | William H Guinty,jr |
Correspondent | William H Guinty,jr MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
Product Code | KZJ |
CFR Regulation Number | 866.2580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-03 |
Decision Date | 1986-06-16 |