SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP— 510(k) K954116
Substantially EquivalentTechnical Products, Inc.
FDA 510(k) clearance K954116 for SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP, Substantially Equivalent on 1995-11-06. Applicant: Technical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Technical Products, Inc.
- Product code
- Code FEW
- Device class
- Class 2
- Regulation
- 21 CFR 876.5090
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Decatur, GA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.