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FDA 510(k)

HANDISOL

K-Number: K924077 · 1992-11-20

ApplicantNational Biological Corp.
Decision Date1992-11-20
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HANDISOL is the device name listed in this FDA 510(k) record. The listed applicant is National Biological Corp.. It received FDA 510(k) clearance on 1992-11-20 under 510(k) number K924077. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDISOL?

HANDISOL is a medical device that received FDA 510(k) clearance on 1992-11-20. The listed applicant is National Biological Corp.. The 510(k) number is K924077.

When did HANDISOL receive FDA 510(k) clearance?

HANDISOL received FDA 510(k) clearance on 1992-11-20, under 510(k) number K924077.

Who is the listed applicant for HANDISOL?

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

What is the FDA product code for HANDISOL?

The FDA product code for HANDISOL is FTC.

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Other records listing National Biological 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.

K070934PANOSOL II TRU-BLU, MODEL UBL-417K041212HOUVA 3 PHOTOTHERAPY SYSTEMK982082HANDISOL WOUND HEALINGK934808UVISOL AND UVISOL IIK924969PHOTOTHERAPY TIMERK904428PANOSOL II UAB-228

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Related Devices (Code: FTC)

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.

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

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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