PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)— 510(k) K972749

Name: FDA 510(k) clearance K972749
Creator: U.S. Food and Drug Administration
Published: 1998-03-13

Substantially Equivalent

C.M. Chance , Ltd.

FDA 510(k) clearance K972749 for PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S), Substantially Equivalent on 1998-03-13. Applicant: C.M. Chance , Ltd.. Device class: 2.

Clearance details

Applicant: C.M. Chance , Ltd.
Product code: Code HQR
Device class: Class 2
Regulation: 21 CFR 886.4100
Advisory panel: Ophthalmic
Date received: 1997-07-23
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southampton, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQR

view all

K050308 — THERMAL CAUTERY PROBE2005-02-25
K990064 — DI-RHEX OPHTHALMIC DIATHERMY SYSTEM1999-04-04
K980522 — REFRACTEC MCS-1001998-07-22
K952151 — STORZ OPHTHALMIC BIPOLAR CAUTERY INSTRUMENTS (D8200, D8201, D8203) AND BIPOLAR CORDS (D8202, D8204)1996-03-04
K955158 — SURGITRON1996-02-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.