The following data is part of a premarket notification filed by Para Scientific Co. with the FDA for Paracon Ii/fecal Concentrator Ii.
Device ID | K021420 |
510k Number | K021420 |
Device Name: | PARACON II/FECAL CONCENTRATOR II |
Classification | Device, Parasite Concentration |
Applicant | PARA SCIENTIFIC CO. 17170 WALL ST. Lake Oswego, OR 97034 |
Contact | Eric Carlson |
Correspondent | Eric Carlson PARA SCIENTIFIC CO. 17170 WALL ST. Lake Oswego, OR 97034 |
Product Code | LKS |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-03 |
Decision Date | 2002-06-04 |