OPPORTUNITY I.V. START KIT
FDA 510(k) clearance K971093 · decided 1997-09-16
Clearance details
- K-number
- K971093
- Device name
- OPPORTUNITY I.V. START KIT
- Applicant
- Opportunity, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1997-03-24
- Decision date
- 1997-09-16
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- MGP
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Highland Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.