Saline Solutine, Sterile

FDA 510(k) K950560 · Busse Hospital Disposables, Inc.

Substantially Equivalent

510(k) numberK950560

Submission

Device name
Saline Solutine, Sterile
Applicant
Busse Hospital Disposables, Inc.
Hauppauge, NY, US
Received
February 8, 1995
Decision date
May 30, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IGE – Solution, Formalin Ammonium Bromide
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

Other 510(k)s with product code IGE

510(k)DeviceApplicantDecision
K842862CB FormalinIGE · Traditional Anatech, Ltd.08/28/1984SE

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Questions and answers

When was Saline Solutine, Sterile cleared by the FDA?

Saline Solutine, Sterile (K950560) received a 510(k) decision of Substantially Equivalent on May 30, 1995, 111 days after the submission was received.

What is the product code of K950560?

The FDA product code is IGE – Solution, Formalin Ammonium Bromide, a Class I (low risk) device regulated under 21 CFR 864.4010.