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FDA 510(k)

UVA HEX UNIT

K-Number: K813307 · 1981-12-31

ApplicantSun Shanty, Inc.
Decision Date1981-12-31
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UVA HEX UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Sun Shanty, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813307. 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 UVA HEX UNIT?

UVA HEX UNIT is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Sun Shanty, Inc.. The 510(k) number is K813307.

When did UVA HEX UNIT receive FDA 510(k) clearance?

UVA HEX UNIT received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813307.

Who is the listed applicant for UVA HEX UNIT?

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

What is the FDA product code for UVA HEX UNIT?

The FDA product code for UVA HEX UNIT is FTC.

Other records listing Sun Shanty, 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.

K832482COMBO UVB/UVA TANNING BOOTHS 8-40-12-36K837032UVB LIGHT BOX TANNING BOOTHK792500UVB LIGHT BOX - UVB LIGHT BOOTH

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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