PANATOME— 510(k) K991518

Substantially Equivalent

Imaging Sciences Intl., Inc.

FDA 510(k) clearance K991518 for PANATOME, Substantially Equivalent on 1999-06-18. Applicant: Imaging Sciences Intl., Inc.. Device class: 2.

Clearance details

Applicant
Imaging Sciences Intl., Inc.
Product code
Code EHD
Device class
Class 2
Regulation
21 CFR 872.1800
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hatfield, PA, US
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