ADVANCED MEDICAL SYSTEMS, KIT— 510(k) K871322

Substantially Equivalent

The Jarid Group, Inc.

FDA 510(k) clearance K871322 for ADVANCED MEDICAL SYSTEMS, KIT, Substantially Equivalent on 1987-05-27. Applicant: The Jarid Group, Inc.. Device class: 2.

Clearance details

Applicant
The Jarid Group, Inc.
Product code
Code LRO
Device class
Class 2
Regulation
21 CFR 878.4370
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wayside, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LRO

product code LRO
Injury
975
Malfunction
14,038
Other
2
Total
15,015

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.