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FDA 510(k)

SANI-SLEEVE DRAPE FOR DENTAL USE

K-Number: K885299 · 1989-03-16

ApplicantNieusma R & D, Inc.
Decision Date1989-03-16
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SANI-SLEEVE DRAPE FOR DENTAL USE is the device name listed in this FDA 510(k) record. The listed applicant is Nieusma R & D, Inc.. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K885299. 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 SANI-SLEEVE DRAPE FOR DENTAL USE?

SANI-SLEEVE DRAPE FOR DENTAL USE is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Nieusma R & D, Inc.. The 510(k) number is K885299.

When did SANI-SLEEVE DRAPE FOR DENTAL USE receive FDA 510(k) clearance?

SANI-SLEEVE DRAPE FOR DENTAL USE received FDA 510(k) clearance on 1989-03-16, under 510(k) number K885299.

Who is the listed applicant for SANI-SLEEVE DRAPE FOR DENTAL USE?

The FDA 510(k) record lists Nieusma R & D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANI-SLEEVE DRAPE FOR DENTAL USE?

The FDA product code for SANI-SLEEVE DRAPE FOR DENTAL USE is EIA.

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 Nieusma R & D, 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.

K892881DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101K892882DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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