RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
FDA 510(k) clearance K881757 · decided 1988-07-15
Clearance details
- K-number
- K881757
- Device name
- RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1988-04-25
- Decision date
- 1988-07-15
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- ETN
- Device class
- 2
- Regulation number
- 874.1820
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Wilmington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.