The following data is part of a premarket notification filed by Molecular Biosystems, Inc. with the FDA for The Extractor(tm).
Device ID | K873932 |
510k Number | K873932 |
Device Name: | THE EXTRACTOR(TM) |
Classification | Adsorbents, Ion-exchange |
Applicant | MOLECULAR BIOSYSTEMS, INC. 10030 BARNES CANYON RD. San Diego, CA 92121 |
Contact | Peter Westkaemper |
Correspondent | Peter Westkaemper MOLECULAR BIOSYSTEMS, INC. 10030 BARNES CANYON RD. San Diego, CA 92121 |
Product Code | DKO |
CFR Regulation Number | 862.2230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-25 |
Decision Date | 1987-11-20 |