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FDA 510(k)

SPONGES, LAPAROTOMY

K-Number: K770446 · 1977-06-15

ApplicantWalpak Co.
Decision Date1977-06-15
Product CodeEFQ
DecisionSubstantially Equivalent

Device Summary

SPONGES, LAPAROTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Walpak Co.. It received FDA 510(k) clearance on 1977-06-15 under 510(k) number K770446. The device is classified under product code EFQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPONGES, LAPAROTOMY?

SPONGES, LAPAROTOMY is a medical device that received FDA 510(k) clearance on 1977-06-15. The listed applicant is Walpak Co.. The 510(k) number is K770446.

When did SPONGES, LAPAROTOMY receive FDA 510(k) clearance?

SPONGES, LAPAROTOMY received FDA 510(k) clearance on 1977-06-15, under 510(k) number K770446.

Who is the listed applicant for SPONGES, LAPAROTOMY?

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 SPONGES, LAPAROTOMY?

The FDA product code for SPONGES, LAPAROTOMY is EFQ.

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Other records listing Walpak Co. 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.

K803200IRRIGATION SET W/BULB SYRINGEK803204IRRIGATION PISTONK803198IRRIGATION SET W/PISTON SYRINGEK803199SUTURE REMOVAL KITK803201LEMON GLYCERINE SWABSK802083CATHETER INSERTION TRAY

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Related Devices (Code: EFQ)

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.

K991757NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILEFurlong IndustriesK991215SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'SSymtex Healthcare Corp.K990974VITOP DRESSINGWonder & Bioenergy Hi-Tech America, Inc.K990584GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLEBroadline Medical IndustriesK984187CROSSTEX NON-WOVEN SPONGESCrosstex Intl.K983016GAUZE, SPONGES, CAT # 11-003Vitalcare Group, 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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