PERICARDIOCENTESIS KIT— 510(k) K802289
Substantially EquivalentStanco Medical, Inc.
FDA 510(k) clearance K802289 for PERICARDIOCENTESIS KIT, Substantially Equivalent on 1980-11-26. Applicant: Stanco Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Stanco Medical, Inc.
- Product code
- Code DOR
- Device class
- Class 2
- Regulation
- 21 CFR 862.3320
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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