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FDA 510(k)

HEMORRELIEF DEVICE

K-Number: K973590 · 1998-02-05

ApplicantA.Stein - Regulatory Affairs Consulting
Decision Date1998-02-05
Product CodeLKX
DecisionSubstantially Equivalent

Device Summary

HEMORRELIEF DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is A.Stein - Regulatory Affairs Consulting. It received FDA 510(k) clearance on 1998-02-05 under 510(k) number K973590. The device is classified under product code LKX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMORRELIEF DEVICE?

HEMORRELIEF DEVICE is a medical device that received FDA 510(k) clearance on 1998-02-05. The listed applicant is A.Stein - Regulatory Affairs Consulting. The 510(k) number is K973590.

When did HEMORRELIEF DEVICE receive FDA 510(k) clearance?

HEMORRELIEF DEVICE received FDA 510(k) clearance on 1998-02-05, under 510(k) number K973590.

Who is the listed applicant for HEMORRELIEF DEVICE?

The FDA 510(k) record lists A.Stein - Regulatory Affairs Consulting as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMORRELIEF DEVICE?

The FDA product code for HEMORRELIEF DEVICE is LKX.

Related Clinical Trials

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.

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Other records listing A.Stein - Regulatory Affairs Consulting 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.

K972383EASY-JET DEVICEK973592WALKCARE P200 SYSTEMK982754EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)K973148MACOM

Related Devices (Code: LKX)

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.

K172358InstaliefPrivi Medical Pte, Ltd.K113660COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICALCryotherapy Products, Inc.K072414CRYOSTATLil Drug Store Products, Inc.K042564HEMOR-RITE CRYOTHERAPHYFama Holdings International CorpK012746ICE BATONBehive, Ltd.K981428ANU ICECryoptherapy Pain Relief Products, Inc.

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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