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FDA 510(k)

PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000

K-Number: K942474 · 1994-10-18

ApplicantProtectaide, Inc.
Decision Date1994-10-18
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 is the device name listed in this FDA 510(k) record. The listed applicant is Protectaide, Inc.. It received FDA 510(k) clearance on 1994-10-18 under 510(k) number K942474. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000?

PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is Protectaide, Inc.. The 510(k) number is K942474.

When did PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 receive FDA 510(k) clearance?

PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 received FDA 510(k) clearance on 1994-10-18, under 510(k) number K942474.

Who is the listed applicant for PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000?

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

What is the FDA product code for PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000?

The FDA product code for PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 is FXX.

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Other records listing Protectaide, 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.

K942468PROTECTAIDE CPR PROTECTION PACK NO. 22100K942469PROTECTAIDE CPR PROTECTION PACKK942471PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. 29777K942472PROTECTAIDE PERSONAL PROTECTION PACK NO. 26123K942473PROTECTAIDE PERSONAL PROTECTION PACK NO. 24592K942476PROTECTAIDE BIOHAZARD CLEAN-UP KIT NO. B3069

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Related Devices (Code: FXX)

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.

K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorO&M Halyard, Inc.K252534Surgical Face Mask (Ear mount)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)Efofex, Inc.K252830Disposable Surgical Face Mask (3P00B, C2900)Beatles Medical Supplies (Xiantao) Co., Ltd.K252650Disposable Medical Face MaskMakrite Industries, Inc.K243342KP Protective Face MaskKp Trading 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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