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FDA 510(k)

ULTIMATE SEAL

K-Number: K960401 · 1996-06-20

ApplicantHans Rudolph, Inc.
Decision Date1996-06-20
Product CodeKGB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ULTIMATE SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Hans Rudolph, Inc.. It received FDA 510(k) clearance on 1996-06-20 under 510(k) number K960401. The device is classified under product code KGB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTIMATE SEAL?

ULTIMATE SEAL is a medical device that received FDA 510(k) clearance on 1996-06-20. The listed applicant is Hans Rudolph, Inc.. The 510(k) number is K960401.

When did ULTIMATE SEAL receive FDA 510(k) clearance?

ULTIMATE SEAL received FDA 510(k) clearance on 1996-06-20, under 510(k) number K960401.

Who is the listed applicant for ULTIMATE SEAL?

The FDA 510(k) record lists Hans Rudolph, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMATE SEAL?

The FDA product code for ULTIMATE SEAL is KGB.

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Other records listing Hans Rudolph, 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.

K071149HRI 6500, 6600 AND 6700 SERIES V2MASKSK0308227600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKSK030515HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKSK0207597600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETITK962848HANS RUDOLPH NASAL CPAP MASKK946077DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS

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Related Devices (Code: KGB)

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.

K970688POCKET RESCUECheen Houng Ent. Co. , Ltd.K941336COMBO MASKGam Industries, Inc.K935917CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVESBd Becton Dickinson Vacutainer Systems PreanalyticK932347COMPACT MASKVital Signs, Inc.K933583NONREBREATHING VALVEHans Rudolph, Inc.K933048LAERDAL(TM) POCKET MASK, MODIFICATIONLaerdal Medical Corp.

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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