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FDA 510(k)

ALLEN MALLEABLE ANESTHESIA SCREEN

K-Number: K873370 · 1987-09-11

ApplicantEdgewater Medical Equipment Systems
Decision Date1987-09-11
Product CodeFWZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ALLEN MALLEABLE ANESTHESIA SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Edgewater Medical Equipment Systems. It received FDA 510(k) clearance on 1987-09-11 under 510(k) number K873370. The device is classified under product code FWZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALLEN MALLEABLE ANESTHESIA SCREEN?

ALLEN MALLEABLE ANESTHESIA SCREEN is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is Edgewater Medical Equipment Systems. The 510(k) number is K873370.

When did ALLEN MALLEABLE ANESTHESIA SCREEN receive FDA 510(k) clearance?

ALLEN MALLEABLE ANESTHESIA SCREEN received FDA 510(k) clearance on 1987-09-11, under 510(k) number K873370.

Who is the listed applicant for ALLEN MALLEABLE ANESTHESIA SCREEN?

The FDA 510(k) record lists Edgewater Medical Equipment Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALLEN MALLEABLE ANESTHESIA SCREEN?

The FDA product code for ALLEN MALLEABLE ANESTHESIA SCREEN is FWZ.

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 Edgewater Medical Equipment Systems 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.

K872900THE PORTABLE ORDERLYK860177ALLEN UNIVERSAL STIRRUP

Related Devices (Code: FWZ)

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.

K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.K945415'LIL MAC ACCESSORY CLAMP(TM)D.L. Nelson and Assoc., Inc.K944779CARBON LIGHTS HAND SURGERY TABLEAllen Medical Systems, Inc.K935381KAPS POSITIONING ARMAndronic Devices, Ltd.K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)Whitmore Ent., Inc.K926225SPONGE COUNTERAmerican Medical Manufacturer, 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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