IMPCO DISPOSABLE AORTIC PUNCH— 510(k) K780247
Substantially EquivalentThoratec Laboratories Corp.
FDA 510(k) clearance K780247 for IMPCO DISPOSABLE AORTIC PUNCH, Substantially Equivalent on 1978-02-27. Applicant: Thoratec Laboratories Corp.. Device class: 1.
Clearance details
- Applicant
- Thoratec Laboratories Corp.
- Product code
- Code DWS
- Device class
- Class 1
- Regulation
- 21 CFR 870.4500
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.