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FDA 510(k)

SYSTEC 280 INTEGRATED SUCTION SYSTEM

K-Number: K791349 · 1979-09-07

ApplicantStryker Corp.
Decision Date1979-09-07
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SYSTEC 280 INTEGRATED SUCTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 1979-09-07 under 510(k) number K791349. 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 SYSTEC 280 INTEGRATED SUCTION SYSTEM?

SYSTEC 280 INTEGRATED SUCTION SYSTEM is a medical device that received FDA 510(k) clearance on 1979-09-07. The listed applicant is Stryker Corp.. The 510(k) number is K791349.

When did SYSTEC 280 INTEGRATED SUCTION SYSTEM receive FDA 510(k) clearance?

SYSTEC 280 INTEGRATED SUCTION SYSTEM received FDA 510(k) clearance on 1979-09-07, under 510(k) number K791349.

Who is the listed applicant for SYSTEC 280 INTEGRATED SUCTION SYSTEM?

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

What is the FDA product code for SYSTEC 280 INTEGRATED SUCTION SYSTEM?

The FDA product code for SYSTEC 280 INTEGRATED SUCTION SYSTEM is BTA.

Related Clinical Trials

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Other records listing Stryker Corp. as applicant

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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

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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