FDA PMA FDA Class 3 Approved 🇺🇸 United States

Intraocular Lens

PMA: P810032 · Decision Apr 23, 1982
Classifications
1
FEI Numbers
59
Registration Numbers
59

Basic Information

Device Name
Intraocular Lens
Trade Name
MODELS B-13F (P-10) & B-1H (P-11)
PMA Number
P810032
Device Class
FDA Class 3
Product Code
HQL
Generic Name
intraocular lens
Regulation Number
886.3600
Medical Specialty
Ophthalmic
Advisory Committee
Ophthalmic
Decision
Approved
Decision Code
APPR
Decision Date
April 23, 1982
Date Received
July 8, 1981
Expedited Review
N
Docket Number
82M-0142

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code Device Name
HQL Intraocular Lens