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FDA 510(k)

SPACELINE THREE WAY SYRINGE

K-Number: K801686 · 1980-08-04

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

Device Summary

SPACELINE THREE WAY SYRINGE 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 K801686. The device is classified under product code ECB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELINE THREE WAY SYRINGE?

SPACELINE THREE WAY SYRINGE 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 K801686.

When did SPACELINE THREE WAY SYRINGE receive FDA 510(k) clearance?

SPACELINE THREE WAY SYRINGE received FDA 510(k) clearance on 1980-08-04, under 510(k) number K801686.

Who is the listed applicant for SPACELINE THREE WAY SYRINGE?

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 THREE WAY SYRINGE?

The FDA product code for SPACELINE THREE WAY SYRINGE is ECB.

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Other records listing Pacific Dental Corp. 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.

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: ECB)

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.

K942519UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPSBull Frog Mfg. Co.K931772SURETIP SYRINGE TIP COVERWestern M/D, Inc.K931137DENTAL SYRINGE TIPA-Dec, Inc.K923876RISKONTROL SINGLE USERiskontrolK923285PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLESmith & Nephew, Inc.K920499SANI-TIPDw Industries, 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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