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FDA 510(k)

DENTIST WITH ASSISTANT PACK

K-Number: K940864 · 1994-08-02

ApplicantSterile Concepts, Inc.
Decision Date1994-08-02
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIST WITH ASSISTANT PACK is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Concepts, Inc.. It received FDA 510(k) clearance on 1994-08-02 under 510(k) number K940864. 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 DENTIST WITH ASSISTANT PACK?

DENTIST WITH ASSISTANT PACK is a medical device that received FDA 510(k) clearance on 1994-08-02. The listed applicant is Sterile Concepts, Inc.. The 510(k) number is K940864.

When did DENTIST WITH ASSISTANT PACK receive FDA 510(k) clearance?

DENTIST WITH ASSISTANT PACK received FDA 510(k) clearance on 1994-08-02, under 510(k) number K940864.

Who is the listed applicant for DENTIST WITH ASSISTANT PACK?

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

What is the FDA product code for DENTIST WITH ASSISTANT PACK?

The FDA product code for DENTIST WITH ASSISTANT PACK is EIA.

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Other records listing Sterile Concepts, 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.

K951231ORTHOPEDIC PACKSK951081OB/GYN PACKSK952539RADIOLOGY PACKSK951478GENERAL AND PLASTIC SURGERY PACKSK944139DENTAL HYGIENE TRAYK943047IV START KITS

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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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