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FDA 510(k)

VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM

K-Number: K883582 · 1988-10-03

ApplicantSurgidyne, Inc.
Decision Date1988-10-03
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Surgidyne, Inc.. It received FDA 510(k) clearance on 1988-10-03 under 510(k) number K883582. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM?

VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM is a medical device that received FDA 510(k) clearance on 1988-10-03. The listed applicant is Surgidyne, Inc.. The 510(k) number is K883582.

When did VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM receive FDA 510(k) clearance?

VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM received FDA 510(k) clearance on 1988-10-03, under 510(k) number K883582.

Who is the listed applicant for VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM?

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 MODEL 250 SUCTION DRAINAGE SYSTEM?

The FDA product code for VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM is BTA.

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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 TUBEK864822VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYSK860030SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2IDK852180SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.K850634SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS

Related Devices (Code: BTA)

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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

Official Source

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

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