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FDA 510(k)

PREP SHAVE KIT (NON-STERILE)

K-Number: K925016 · 1993-04-26

ApplicantCustomed, Inc.
Decision Date1993-04-26
Product CodeLRO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PREP SHAVE KIT (NON-STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Customed, Inc.. It received FDA 510(k) clearance on 1993-04-26 under 510(k) number K925016. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREP SHAVE KIT (NON-STERILE)?

PREP SHAVE KIT (NON-STERILE) is a medical device that received FDA 510(k) clearance on 1993-04-26. The listed applicant is Customed, Inc.. The 510(k) number is K925016.

When did PREP SHAVE KIT (NON-STERILE) receive FDA 510(k) clearance?

PREP SHAVE KIT (NON-STERILE) received FDA 510(k) clearance on 1993-04-26, under 510(k) number K925016.

Who is the listed applicant for PREP SHAVE KIT (NON-STERILE)?

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

What is the FDA product code for PREP SHAVE KIT (NON-STERILE)?

The FDA product code for PREP SHAVE KIT (NON-STERILE) is LRO.

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Other records listing Customed, 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.

K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)K964011SUCTION CATHETER TRAY PRODUCT NO. 900277K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)K962596CUSTOMED BLOOD EXTRACTION KITK961442UNIVERSAL DRAINAGE TRAY

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Related Devices (Code: LRO)

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.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

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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