SURGITEK DISPOSABLE FLO-RESTER— 510(k) K781336

Name: FDA 510(k) clearance K781336
Creator: U.S. Food and Drug Administration
Published: 1978-10-10

Substantially Equivalent

Medical Engineering Corp.

FDA 510(k) clearance K781336 for SURGITEK DISPOSABLE FLO-RESTER, Substantially Equivalent on 1978-10-10. Applicant: Medical Engineering Corp.. Device class: 1.

Clearance details

Applicant: Medical Engineering Corp.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1978-08-03
Decision date: 1978-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWS

view all

K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 106262002-10-09
K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)1997-01-30
K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS1996-11-19
K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY1996-05-15
K960139 — G.E. STERILE ANGIOGRAPHIC TRAY1996-04-19

More clearances from Medical Engineering Corp.

view all

K934141 — STAND ALONE CYSTOMETROGRAM1993-11-18
K905289 — SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT1991-03-13
K903448 — SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER1991-01-14
K902773 — SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET1990-07-16
K884746 — SURGITEK FLAT T-SPAN1989-08-10

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