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FDA 510(k)

SPACELINE HIGH VOLUME EVACUATION HANDPIE

K-Number: K801682 · 1980-08-04

ApplicantPacific Dental Corp.
Decision Date1980-08-04
Product CodeEHZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPACELINE HIGH VOLUME EVACUATION HANDPIE is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Dental Corp.. It received FDA 510(k) clearance on 1980-08-04 under 510(k) number K801682. 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 SPACELINE HIGH VOLUME EVACUATION HANDPIE?

SPACELINE HIGH VOLUME EVACUATION HANDPIE is a medical device that received FDA 510(k) clearance on 1980-08-04. The listed applicant is Pacific Dental Corp.. The 510(k) number is K801682.

When did SPACELINE HIGH VOLUME EVACUATION HANDPIE receive FDA 510(k) clearance?

SPACELINE HIGH VOLUME EVACUATION HANDPIE received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801682.

Who is the listed applicant for SPACELINE HIGH VOLUME EVACUATION HANDPIE?

The FDA 510(k) record lists Pacific Dental Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPACELINE HIGH VOLUME EVACUATION HANDPIE?

The FDA product code for SPACELINE HIGH VOLUME EVACUATION HANDPIE is EHZ.

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Other records listing Pacific Dental Corp. as applicant

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K821782BEACH ANESTHETIC SYRINGE CARTR. TYPEK821779BEACH AMALGAM CARRIER, GUN TYPEK821789BEACH CURETTE NO. 2 AND NO. 3 T.G.K821777BEACH MOUTH MIRRORK821778BEACH DRESSING PLIERK821780BEACH EXPLORER NO. 23T.G.

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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.K892881DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101Nieusma R & D, Inc.K892882DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102Nieusma R & D, Inc.

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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