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FDA 510(k)

PDS-2000

K-Number: K902653 · 1990-09-13

ApplicantIntl. Equipment and Supply Corp.
Decision Date1990-09-13
Product CodeEIK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PDS-2000 is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Equipment and Supply Corp.. It received FDA 510(k) clearance on 1990-09-13 under 510(k) number K902653. The device is classified under product code EIK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PDS-2000?

PDS-2000 is a medical device that received FDA 510(k) clearance on 1990-09-13. The listed applicant is Intl. Equipment and Supply Corp.. The 510(k) number is K902653.

When did PDS-2000 receive FDA 510(k) clearance?

PDS-2000 received FDA 510(k) clearance on 1990-09-13, under 510(k) number K902653.

Who is the listed applicant for PDS-2000?

The FDA 510(k) record lists Intl. Equipment and Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PDS-2000?

The FDA product code for PDS-2000 is EIK.

Related Devices (Code: EIK)

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.

K013993NEOCALEXStephen M Koral, DmdK972642PERIO CONTROL IIEstrad B.V.K860817ROOT CANAL ORGANIZERPacific Union Dental, Inc.K8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAArtiberia

Official Source

View on FDA Database →

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