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FDA 510(k)

VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS

K-Number: K864822 · 1987-01-15

ApplicantSurgidyne, Inc.
Decision Date1987-01-15
Product CodeBTC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Surgidyne, Inc.. It received FDA 510(k) clearance on 1987-01-15 under 510(k) number K864822. The device is classified under product code BTC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS?

VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS is a medical device that received FDA 510(k) clearance on 1987-01-15. The listed applicant is Surgidyne, Inc.. The 510(k) number is K864822.

When did VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS receive FDA 510(k) clearance?

VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS received FDA 510(k) clearance on 1987-01-15, under 510(k) number K864822.

Who is the listed applicant for VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS?

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

What is the FDA product code for VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS?

The FDA product code for VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS is BTC.

Related Clinical Trials

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.

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Other records listing Surgidyne, 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.

K892334LEONARD TUBEK883582VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEMK860030SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2IDK852180SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.K850634SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS

Related Devices (Code: BTC)

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.

K181424PeDIAPedia, LLCK940220REBREATHER BAGSZefon Medical ProductsK932496PRECISION MED PRODUCTS, LTD. BREATHING BAGSPrecision Med Products, Ltd.K932581BREATHING BAGSMed-Plastics Intl., Inc.K932584BREATHING BAGSMerit Medical Systems, Inc.K932191BREATHING BAGSLife Shield Healthcare Products, 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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