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FDA 510(k)

ALPHA SHOPPER

K-Number: K893428 · 1989-06-12

ApplicantAlpha Unlimited, Inc.
Decision Date1989-06-12
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ALPHA SHOPPER is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Unlimited, Inc.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K893428. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHA SHOPPER?

ALPHA SHOPPER is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Alpha Unlimited, Inc.. The 510(k) number is K893428.

When did ALPHA SHOPPER receive FDA 510(k) clearance?

ALPHA SHOPPER received FDA 510(k) clearance on 1989-06-12, under 510(k) number K893428.

Who is the listed applicant for ALPHA SHOPPER?

The FDA 510(k) record lists Alpha Unlimited, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALPHA SHOPPER?

The FDA product code for ALPHA SHOPPER is ITI.

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Other records listing Alpha Unlimited, 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.

K894646#556 DISPOSABLE UMBILICAL CORD CLAMP (2)K893429ALPHA CONDORK893248ALPHA MALLARDK853766ALPHA SUPER KARTK841921ALPHA PLUS 1K841911ALPHA PUSH KART

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Related Devices (Code: ITI)

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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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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