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FDA 510(k)

WALDMANN F85/100W UV21

K-Number: K852684 · 1985-07-11

ApplicantSylvania Lighting Products
Decision Date1985-07-11
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WALDMANN F85/100W UV21 is the device name listed in this FDA 510(k) record. The listed applicant is Sylvania Lighting Products. It received FDA 510(k) clearance on 1985-07-11 under 510(k) number K852684. 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 WALDMANN F85/100W UV21?

WALDMANN F85/100W UV21 is a medical device that received FDA 510(k) clearance on 1985-07-11. The listed applicant is Sylvania Lighting Products. The 510(k) number is K852684.

When did WALDMANN F85/100W UV21 receive FDA 510(k) clearance?

WALDMANN F85/100W UV21 received FDA 510(k) clearance on 1985-07-11, under 510(k) number K852684.

Who is the listed applicant for WALDMANN F85/100W UV21?

The FDA 510(k) record lists Sylvania Lighting Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WALDMANN F85/100W UV21?

The FDA product code for WALDMANN F85/100W UV21 is FTC.

Related Clinical Trials

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Other records listing Sylvania Lighting Products 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.

K852575WALDMANN F85/100W PUVAK852321SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVAK852576WALDMANN F85/100W UV6

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

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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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