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FDA 510(k)

CELL RECOVERY SYSTEM

K-Number: K965037 · 1997-01-08

ApplicantMedical Device Technologies, Inc.
Decision Date1997-01-08
Product CodeFDX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CELL RECOVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 1997-01-08 under 510(k) number K965037. The device is classified under product code FDX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELL RECOVERY SYSTEM?

CELL RECOVERY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-08. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K965037.

When did CELL RECOVERY SYSTEM receive FDA 510(k) clearance?

CELL RECOVERY SYSTEM received FDA 510(k) clearance on 1997-01-08, under 510(k) number K965037.

Who is the listed applicant for CELL RECOVERY SYSTEM?

The FDA 510(k) record lists Medical Device Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CELL RECOVERY SYSTEM?

The FDA product code for CELL RECOVERY SYSTEM is FDX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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