FDA 510(k) Premarket Notification K883982: DRENOVAC

Submission Details & Decision

Normalized public record details for 510(k) notification K883982.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K883982

Applicant / Sponsor

Iberhospitex, S.A.

Device Name

DRENOVAC

Product Code

GCY

Decision Date

1989-02-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

General, Plastic Surgery (SU)

Clearance Type

Traditional

Third Party Flag

Date Received

1988-09-20

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