OVAL SHAPES— 510(k) K973385
Substantially EquivalentTechnical Products, Inc.
FDA 510(k) clearance K973385 for OVAL SHAPES, Substantially Equivalent on 1997-12-05. Applicant: Technical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Technical Products, Inc.
- Product code
- Code HXA
- Device class
- Class 2
- Regulation
- 21 CFR 888.3025
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Decatur, GA, US
Recent devices under product code HXA
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- K971472 — SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA
- K971613 — SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING
- K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
Data sourced from openFDA. This site is unofficial and independent of the FDA.