L.T.C. REPLACEMENT GASTROSTOMY TUBE
FDA 510(k) clearance K896621 · decided 1990-03-13
Clearance details
- K-number
- K896621
- Device name
- L.T.C. REPLACEMENT GASTROSTOMY TUBE
- Applicant
- Intl. Medical Marketing, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-11-21
- Decision date
- 1990-03-13
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- KCQ
- Device class
- 1
- Regulation number
- 872.6570
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ridge, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.