SE-300 VACUUM THERAPY SYSTEM— 510(k) K012639

Substantially Equivalent

Vts, Inc.

FDA 510(k) clearance K012639 for SE-300 VACUUM THERAPY SYSTEM, Substantially Equivalent on 2001-11-09. Applicant: Vts, Inc.. Device class: 2.

Clearance details

Applicant: Vts, Inc.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 2001-08-13
Decision date: 2001-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newkirk, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKY

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K030913 — NANMA VACUUM PUMP2003-06-03
K013113 — MODIFICATION TO NANMA VACUUM PUMP2002-12-20

More clearances from Vts, Inc.

K012619 — VT-12001-11-09
K012620 — SE-2002001-11-09
K012662 — SE-100 VACUUM ERECTION DEVICE2001-11-09
K992442 — V.T.S., INC. (V.T.-3)1999-10-05

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