NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR— 510(k) K952847
Substantially EquivalentAce 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.. Device class: 2.
Clearance details
- Applicant
- Ace Surgical Supply Co., Inc.
- Product code
- Code MQN
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brockton, MA, US
Recent devices under product code MQN
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- K061397 — ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
Adverse events under product code MQN
product code MQN- Injury
- 346
- Total
- 346
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.