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FDA 510(k)

DEN-Z-ORB

K-Number: K780400 · 1978-03-27

ApplicantNice-Pak Products, Inc.
Decision Date1978-03-27
Product CodeKHR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DEN-Z-ORB is the device name listed in this FDA 510(k) record. The listed applicant is Nice-Pak Products, Inc.. It received FDA 510(k) clearance on 1978-03-27 under 510(k) number K780400. 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 DEN-Z-ORB?

DEN-Z-ORB is a medical device that received FDA 510(k) clearance on 1978-03-27. The listed applicant is Nice-Pak Products, Inc.. The 510(k) number is K780400.

When did DEN-Z-ORB receive FDA 510(k) clearance?

DEN-Z-ORB received FDA 510(k) clearance on 1978-03-27, under 510(k) number K780400.

Who is the listed applicant for DEN-Z-ORB?

The FDA 510(k) record lists Nice-Pak Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEN-Z-ORB?

The FDA product code for DEN-Z-ORB is KHR.

Other records listing Nice-Pak Products, 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.

K974768PDI STERILE LUBRICATING JELLYK840343PDI PREPMASTER WET PACK VAGINAL-X21477K840342PDI PREPMASTER WET PACK PATIENT PREP KITK840344PDI PREPMASTER WET PACK MINOR PROCEDUREK833549PDI SURGICAL SCRUB/BRUSH T150-70K810337PDI SURGICAL SCRUB SPONGE-BRUSH-T15070

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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.

K980783SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5Irt Management Corp.K954068GENERAL HYGIENE KITPhysician Industries, Inc.K953812GAUZE SPONGERemington Medical, Inc.K891054NON-STERILE GAUZE SPONGEDispomed, Inc.K891354ORTHODONTIC COTTON ROLL HOLDERSAmerican OrthodonticsK890734DRY TIPSMicrocopy, Div. Neo-Flo, 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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