PERCUTANEOUS INTRODUCER KIT
FDA 510(k) clearance K902135 · decided 1990-08-01
Clearance details
- K-number
- K902135
- Device name
- PERCUTANEOUS INTRODUCER KIT
- Applicant
- Device Labs, Inc.
- Decision
- Unknown
- Date received
- 1990-05-10
- Decision date
- 1990-08-01
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Medway, MA, US
- Third-party review
- No
- Expedited review
- No
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