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FDA 510(k)

SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5

K-Number: K980783 · 1998-04-21

ApplicantIrt Management Corp.
Decision Date1998-04-21
Product CodeKHR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 is the device name listed in this FDA 510(k) record. The listed applicant is Irt Management Corp.. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K980783. The device is classified under product code KHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5?

SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Irt Management Corp.. The 510(k) number is K980783.

When did SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 receive FDA 510(k) clearance?

SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 received FDA 510(k) clearance on 1998-04-21, under 510(k) number K980783.

Who is the listed applicant for SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5?

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

What is the FDA product code for SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5?

The FDA product code for SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5 is KHR.

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Other records listing Irt Management 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.

K980672SIMPLEX AIRBRATOR (SAB-7)

Related Devices (Code: KHR)

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.

K954068GENERAL HYGIENE KITPhysician Industries, Inc.K953812GAUZE SPONGERemington Medical, Inc.K891054NON-STERILE GAUZE SPONGEDispomed, Inc.K891354ORTHODONTIC COTTON ROLL HOLDERSAmerican OrthodonticsK890734DRY TIPSMicrocopy, Div. Neo-Flo, Inc.K870383ALGINATE WOOL FIBERAdri

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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