ORS-1000— 510(k) K915427

Substantially Equivalent

Mnlase, Inc.

FDA 510(k) clearance K915427 for ORS-1000, Substantially Equivalent on 1992-01-07. Applicant: Mnlase, Inc.. Device class: 1.

Clearance details

Applicant: Mnlase, Inc.
Product code: Code JRM
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1991-12-02
Decision date: 1992-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reston, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JRM

K921568 — ORS-1001992-06-09
K921569 — ORS-2001992-06-09
K921570 — ORS-3001992-06-09
K913777 — SELF-CONTAINED SURGICAL SLUSH FREEZER1991-09-25
K894006 — SANISERV SURGICAL SLUSH SYSTEM1989-11-03

More clearances from Mnlase, Inc.

K944630 — MODEL 230-SAS LASER DELIVERY PROBE1994-11-09
K944470 — CURVED ENDOPHOTOCOAGULATOR LASER PROBE1994-11-03
K944471 — STRAIGHT ENDOPHOTOCOAGULATOR LASER PROBE1994-11-03
K944625 — MODEL 210-AC ASPIRATING ENDOPHOTOCOAGULATOR LASER1994-11-03
K944626 — MODEL 210-AS ASPIRATING ENDOPHOTOCOAGULATOR LASER1994-11-03

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