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FDA 510(k)

4631 DUO DELIVERY SYSTEM

K-Number: K000966 · 2000-05-03

ApplicantA-Dec, Inc.
Decision Date2000-05-03
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

4631 DUO DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A-Dec, Inc.. It received FDA 510(k) clearance on 2000-05-03 under 510(k) number K000966. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4631 DUO DELIVERY SYSTEM?

4631 DUO DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-03. The listed applicant is A-Dec, Inc.. The 510(k) number is K000966.

When did 4631 DUO DELIVERY SYSTEM receive FDA 510(k) clearance?

4631 DUO DELIVERY SYSTEM received FDA 510(k) clearance on 2000-05-03, under 510(k) number K000966.

Who is the listed applicant for 4631 DUO DELIVERY SYSTEM?

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

What is the FDA product code for 4631 DUO DELIVERY SYSTEM?

The FDA product code for 4631 DUO DELIVERY SYSTEM is EIA.

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Other records listing A-Dec, 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.

K213932A-dec 300, A-dec 500K102234A-DEC 200 DENTAL SYSTEMK100647A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMK082716A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43K082827A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENTK082985A-DEC 334/335 DELIVERY SYSTEM

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Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, 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.

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