SPR PLUS II OVERLAY SYSTEM (CL250/CL212— 510(k) K961854

Substantially Equivalent

Gaymar Industries, Inc.

FDA 510(k) clearance K961854 for SPR PLUS II OVERLAY SYSTEM (CL250/CL212, Substantially Equivalent on 1996-08-09. Applicant: Gaymar Industries, Inc..

Clearance details

Applicant: Gaymar Industries, Inc.
Product code: Code FNM
Advisory panel: General Hospital
Date received: 1996-05-14
Decision date: 1996-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orchard Park, NY, US

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Adverse events under product code FNM

product code FNM

Death: 22
Injury: 349
Other: 4
Total: 375

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.