NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR— 510(k) K952847

Substantially Equivalent

Ace Surgical Supply Co., Inc.

FDA 510(k) clearance K952847 for NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR, Substantially Equivalent on 1996-02-06. Applicant: Ace Surgical Supply Co., Inc..

Clearance details

Applicant: Ace Surgical Supply Co., Inc.
Product code: Code MQN
Advisory panel: Dental
Date received: 1995-06-21
Decision date: 1996-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brockton, MA, US

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Adverse events under product code MQN

product code MQN

Injury: 346
Total: 346

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.