FDA 510(k) Premarket Notification K981334: LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)

Submission Details & Decision

Normalized public record details for 510(k) notification K981334.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K981334

Applicant / Sponsor

Richard Wolf Medical Instruments Corp.

Device Name

LAPARO CO2-PNEU (AND WITH VIDEO MONITORING)

Product Code

HIF

Decision Date

1998-09-10

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Obstetrics/Gynecology (OB)

Clearance Type

Traditional

Third Party Flag

Date Received

1998-04-13

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