HNI · Class I · 21 CFR 886.4350

FDA Product Code HNI: Retractor, Ophthalmic

Leading manufacturers include Concept, Inc. and KARL STORZ Endoscopy-America, Inc..

2
Total
2
Cleared
97d
Avg days
1977
Since

FDA 510(k) Cleared Retractor, Ophthalmic Devices (Product Code HNI)

2 devices
1–2 of 2
Cleared Nov 02, 1999
KSEA DE LA PLAZA BLEPHAROPLASTY SET
K991592
KARL STORZ Endoscopy-America, Inc.
Ophthalmic · 179d
Cleared Feb 17, 1977
IRIS RETRACTOR
K770222
Concept, Inc.
Ophthalmic · 14d

About Product Code HNI - Regulatory Context