PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI— 510(k) K882381
Substantially EquivalentPioneering Technologies, Inc.
FDA 510(k) clearance K882381 for PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI, Substantially Equivalent on 1988-07-07. Applicant: Pioneering Technologies, Inc.. Device class: 1.
Clearance details
- Applicant
- Pioneering Technologies, Inc.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lakewood, CO, US
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