REPLACE-A-TIP RECHARGEABLE HIGH TEMP— 510(k) K841326

Substantially Equivalent

Suncoast Medical Manufacturers, Inc.

FDA 510(k) clearance K841326 for REPLACE-A-TIP RECHARGEABLE HIGH TEMP, Substantially Equivalent on 1984-05-09. Applicant: Suncoast Medical Manufacturers, Inc.. Device class: 2.

Clearance details

Applicant
Suncoast Medical Manufacturers, Inc.
Product code
Code HQP
Device class
Class 2
Regulation
21 CFR 886.4115
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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