GARDNER KUPHOSIS DISTRACTOR
FDA 510(k) clearance K802851 · decided 1981-02-17
Clearance details
- K-number
- K802851
- Device name
- GARDNER KUPHOSIS DISTRACTOR
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-12
- Decision date
- 1981-02-17
- Days to decision
- 97 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Downs Surgical
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.