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FDA 510(k)

BIODYNE INSTRUMENT WIPES

K-Number: K900691 · 1990-03-08

ApplicantBio-Dyne, Inc.
Decision Date1990-03-08
Product CodeGEC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BIODYNE INSTRUMENT WIPES is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Dyne, Inc.. It received FDA 510(k) clearance on 1990-03-08 under 510(k) number K900691. The device is classified under product code GEC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODYNE INSTRUMENT WIPES?

BIODYNE INSTRUMENT WIPES is a medical device that received FDA 510(k) clearance on 1990-03-08. The listed applicant is Bio-Dyne, Inc.. The 510(k) number is K900691.

When did BIODYNE INSTRUMENT WIPES receive FDA 510(k) clearance?

BIODYNE INSTRUMENT WIPES received FDA 510(k) clearance on 1990-03-08, under 510(k) number K900691.

Who is the listed applicant for BIODYNE INSTRUMENT WIPES?

The FDA 510(k) record lists Bio-Dyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIODYNE INSTRUMENT WIPES?

The FDA product code for BIODYNE INSTRUMENT WIPES is GEC.

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Other records listing Bio-Dyne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K883984HEMORX COLD PACKK864261MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR

Related Devices (Code: GEC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCKM-Pact Worldwide Management Corp.K960621EXPANDACELL INSTRUMENT WIPEShippert Medical Technologies Corp.K896085SURGI-BRUSHSparta Surgical Corp.K875033STERILE SCRUBBY SCRUB BRUSHMedsurg Industries, Inc.K875129STERI-CLENSAbsorbent Cotton Co., Inc.K872823DELTA SCRUBPacific Biosystems, Inc.

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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