HRC — Sterilizer, Soft-Lens, Thermal, Battery-Powered Class II

FDA Device Classification

FDA product code HRC covers "Sterilizer, Soft-Lens, Thermal, Battery-Powered", a Class II medical device regulated under 21 CFR 886.5928. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
HRC
Device Class
Class II
Regulation Number
886.5928
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K920037osteoOSTEO COMPRESSION HIP SCREWMarch 11, 1992