NTI CLENCHING SUPPRESSION SYSTEM
FDA 510(k) clearance K981546 · decided 1998-07-15
Clearance details
- K-number
- K981546
- Device name
- NTI CLENCHING SUPPRESSION SYSTEM
- Applicant
- Heraeus Kulzer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-30
- Decision date
- 1998-07-15
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- MQC
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- South Bend, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.