TYGON PAC-STOPCOCKS
FDA 510(k) clearance K770708 · decided 1977-06-08
Clearance details
- K-number
- K770708
- Device name
- TYGON PAC-STOPCOCKS
- Applicant
- Norton Performance Plastics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-18
- Decision date
- 1977-06-08
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- FMG
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.