The following data is part of a premarket notification filed by Poretics Corp. with the FDA for Pcte Microporous Membrane Filter.
Device ID | K870196 |
510k Number | K870196 |
Device Name: | PCTE MICROPOROUS MEMBRANE FILTER |
Classification | Filters, Cell Collection, Tissue Processing |
Applicant | PORETICS CORP. 151 I LINDBERGH AVE. Livermore, CA 94550 |
Contact | Harold W Ballew |
Correspondent | Harold W Ballew PORETICS CORP. 151 I LINDBERGH AVE. Livermore, CA 94550 |
Product Code | KET |
CFR Regulation Number | 864.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-20 |
Decision Date | 1987-05-12 |