The following data is part of a premarket notification filed by Para Scientific Co. with the FDA for Para Con Tm.
Device ID | K853715 |
510k Number | K853715 |
Device Name: | PARA CON TM |
Classification | Device, Parasite Concentration |
Applicant | PARA SCIENTIFIC CO. 4155 MELISSA DR. Lake Oswego, OR 97034 |
Contact | Bonny J Carlson |
Correspondent | Bonny J Carlson PARA SCIENTIFIC CO. 4155 MELISSA DR. 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 | 1985-09-04 |
Decision Date | 1985-10-02 |