MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
FDA 510(k) clearance K872230 · decided 1987-09-15
Clearance details
- K-number
- K872230
- Device name
- MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE
- Applicant
- Intermedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-09
- Decision date
- 1987-09-15
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- DBT
- Device class
- 1
- Regulation number
- 866.5330
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Freeport, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.