FDA 510(k)

IRRIGATION SET W/BULB SYRINGE

K-Number: K803200 · 1981-01-21

Decision Date1981-01-21

Product CodeKYZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

IRRIGATION SET W/BULB SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Walpak Co.. It received FDA 510(k) clearance on 1981-01-21 under 510(k) number K803200. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRRIGATION SET W/BULB SYRINGE?

IRRIGATION SET W/BULB SYRINGE is a medical device that received FDA 510(k) clearance on 1981-01-21. The listed applicant is Walpak Co.. The 510(k) number is K803200.

When did IRRIGATION SET W/BULB SYRINGE receive FDA 510(k) clearance?

IRRIGATION SET W/BULB SYRINGE received FDA 510(k) clearance on 1981-01-21, under 510(k) number K803200.

Who is the listed applicant for IRRIGATION SET W/BULB SYRINGE?

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

What is the FDA product code for IRRIGATION SET W/BULB SYRINGE?

The FDA product code for IRRIGATION SET W/BULB SYRINGE is KYZ.

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Other records listing Walpak Co. as applicant

K803204IRRIGATION PISTON K803198IRRIGATION SET W/PISTON SYRINGE K803199SUTURE REMOVAL KIT K803201LEMON GLYCERINE SWABS K802083CATHETER INSERTION TRAY K791598CLOSED SYSTEM FOLEY CATHERIZATION PROCED

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Related Devices (Code: KYZ)

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, 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.