FDA 510(k)

STERILE ABDOMINAL PAD

K-Number: K801068 · 1980-05-20

Decision Date1980-05-20

Product CodeKKX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

STERILE ABDOMINAL PAD is the device name listed in this FDA 510(k) record. The listed applicant is Medspec Corp.. It received FDA 510(k) clearance on 1980-05-20 under 510(k) number K801068. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE ABDOMINAL PAD?

STERILE ABDOMINAL PAD is a medical device that received FDA 510(k) clearance on 1980-05-20. The listed applicant is Medspec Corp.. The 510(k) number is K801068.

When did STERILE ABDOMINAL PAD receive FDA 510(k) clearance?

STERILE ABDOMINAL PAD received FDA 510(k) clearance on 1980-05-20, under 510(k) number K801068.

Who is the listed applicant for STERILE ABDOMINAL PAD?

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

What is the FDA product code for STERILE ABDOMINAL PAD?

The FDA product code for STERILE ABDOMINAL PAD is KKX.

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Other records listing Medspec Corp. as applicant

K813012STERILE BASIN SETS K812710STERILE LAPAROTOMY SPONGES-X-RAY DETECT K812707STERILE DISSECTOR SPONGES-X-RAY DETECT K812711STERILE GAUZE PADS 12PLY K812709STERILE DENTAL ROLL K810071STERILE SILICONE TUBING

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Related Devices (Code: KKX)

K230645BeneHold™ Surgical Incise Drape with CHG antimicrobial IIAvery Dennison Medical , Ltd.K2225783M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)3M Company K202208BeneHold Surgical Incise Drape with CHG antimicrobialAvery Dennison Belgie Bvba K200238ControlRad Sterile CoverControlrad, Inc.K163556MediClear PreOpCovalontechnologies, Inc.K130404TIBURON SURGICAL DRAPECardinal Health200, LLC

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.