510(k) K984436

PVS BASICS by Paragon Vision Sciences — Product Code HQD

K984436 is an FDA 510(k) premarket notification submitted by Paragon Vision Sciences for the device "PVS BASICS". The FDA issued a decision of Substantially Equivalent on April 21, 1999. The device falls under product code HQD (Lens, Contact (Other Material) - Daily), a Class II device regulated under 21 CFR 886.5916. Paragon Vision Sciences has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1999
Date Received
December 14, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type