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FDA 510(k)

REPRO-MED NEONATE ASPIRATION SYSTEM

K-Number: K892529 · 1989-06-12

ApplicantRepro-Med Systems, Inc.
Decision Date1989-06-12
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

REPRO-MED NEONATE ASPIRATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K892529. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPRO-MED NEONATE ASPIRATION SYSTEM?

REPRO-MED NEONATE ASPIRATION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Repro-Med Systems, Inc.. The 510(k) number is K892529.

When did REPRO-MED NEONATE ASPIRATION SYSTEM receive FDA 510(k) clearance?

REPRO-MED NEONATE ASPIRATION SYSTEM received FDA 510(k) clearance on 1989-06-12, under 510(k) number K892529.

Who is the listed applicant for REPRO-MED NEONATE ASPIRATION SYSTEM?

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

What is the FDA product code for REPRO-MED NEONATE ASPIRATION SYSTEM?

The FDA product code for REPRO-MED NEONATE ASPIRATION SYSTEM is BSY.

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 Repro-Med Systems, 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.

K102512RMS SUBCUTANEOUS NEEDLE SETK981506RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)K933652FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBINGK894299REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEMK844401REPRO-MED SYSTEMS INFUSION DEVICE

Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.

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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