510(k) K864343

BL1 (HARD CONTACT LENS) by Beta Labs, Inc. — Product Code HPX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 28, 1986
Date Received
November 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Polymethylmethacrylate)
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type