ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE— 510(k) K864946

Name: FDA 510(k) clearance K864946
Creator: U.S. Food and Drug Administration
Published: 1988-01-28

Substantially Equivalent

Bio Quantum Technologies, Inc.

FDA 510(k) clearance K864946 for ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE, Substantially Equivalent on 1988-01-28. Applicant: Bio Quantum Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Bio Quantum Technologies, Inc.
Product code: Code HHR
Device class: Class 2
Regulation: 21 CFR 884.4550
Advisory panel: Obstetrics/Gynecology
Date received: 1986-12-17
Decision date: 1988-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE1988-06-01

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K934089 — BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S1994-02-03
K864887 — ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU1987-04-10
K864948 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE1987-03-30
K840406 — MICROSURGICAL CO2 LASER SYS - 41001984-08-20
K837110 — MODEL 4100 MICROSURGICAL CO2 LASER SYSTEM1983-03-11

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