H-H HUNTER PASSIVE TENDON IMPLANT— 510(k) K853436

Name: FDA 510(k) clearance K853436
Creator: U.S. Food and Drug Administration
Published: 1985-10-16

Substantially Equivalent

Holter-Hausner Intl.

FDA 510(k) clearance K853436 for H-H HUNTER PASSIVE TENDON IMPLANT, Substantially Equivalent on 1985-10-16. Applicant: Holter-Hausner Intl.. Device class: 1.

Clearance details

Applicant: Holter-Hausner Intl.
Product code: Code HXR
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1985-08-15
Decision date: 1985-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgeport, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HXR

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K983882 — MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-14001999-03-15
K873387 — VIDEO ARTHROSCOPE, 1.7MM X 55 MM1987-11-25
K872281 — RAYLOR FUSION FUNNEL1987-11-02

More clearances from Holter-Hausner Intl.

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K875287 — H-H FLUSHING RESERVOIR1988-07-14
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K872284 — H-H HUNTER ACTIVE TENDON IMPLANT PC1987-09-28
K872285 — H-H HUNTER ACTIVE TENDON IMPLANT DC1987-09-28
K872293 — H-H HUNTER ACTIVE TENDON IMPLANT BC1987-09-28

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