NAMIC HAWKINS UNIVERSAL DRAINAGE SET
FDA 510(k) clearance K873954 · decided 1988-01-29
Clearance details
- K-number
- K873954
- Device name
- NAMIC HAWKINS UNIVERSAL DRAINAGE SET
- Applicant
- North American Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-28
- Decision date
- 1988-01-29
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Glens Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.