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FDA 510(k)

DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101

K-Number: K892881 · 1989-06-23

ApplicantNieusma R & D, Inc.
Decision Date1989-06-23
Product CodeEHZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 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 1989-06-23 under 510(k) number K892881. The device is classified under product code EHZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101?

DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Nieusma R & D, Inc.. The 510(k) number is K892881.

When did DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 receive FDA 510(k) clearance?

DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892881.

Who is the listed applicant for DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101?

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 DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101?

The FDA product code for DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 is EHZ.

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.

K892882DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102K885299SANI-SLEEVE DRAPE FOR DENTAL USE

Related Devices (Code: EHZ)

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.

K973248IMTEC BONE COLLECTOR SYSTEMImtec Corp.K941164TAP EXPRESS EJECTORTap Express, Inc.K911072SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATORA & F ProductsK903718OROSCOPE MODEL NUMBER COS-100Cygnus Instruments, Inc.K892882DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102Nieusma R & D, Inc.K880754DRI-CLAVE LIQUID KLEENZALLColumbus Dental Mfg. Co.

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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