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FDA 510(k)

SINGLE USE INSTRUMENT TRAY

K-Number: K951149 · 1995-04-06

ApplicantMedcare Custom Packaging, Inc.
Decision Date1995-04-06
Product CodeLRO
Advisory CommitteeSU
DecisionUnknown

Device Summary

SINGLE USE INSTRUMENT TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Medcare Custom Packaging, Inc.. It received FDA 510(k) clearance on 1995-04-06 under 510(k) number K951149. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SINGLE USE INSTRUMENT TRAY?

SINGLE USE INSTRUMENT TRAY is a medical device that received FDA 510(k) clearance on 1995-04-06. The listed applicant is Medcare Custom Packaging, Inc.. The 510(k) number is K951149.

When did SINGLE USE INSTRUMENT TRAY receive FDA 510(k) clearance?

SINGLE USE INSTRUMENT TRAY received FDA 510(k) clearance on 1995-04-06, under 510(k) number K951149.

Who is the listed applicant for SINGLE USE INSTRUMENT TRAY?

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

What is the FDA product code for SINGLE USE INSTRUMENT TRAY?

The FDA product code for SINGLE USE INSTRUMENT TRAY is LRO.

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Other records listing Medcare Custom Packaging, 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.

K954869MEDCARE YANKAUER SUCTION DEVICEK954442STERILE ISOTONIC SALINE & STERILE WATERK952759TOWEL PACKK950390URETHRAL CATHETERIZATION TRAYK943661STERILE PHYSIOLOGICAL SALINE/STERILE WATERK934732PELVIC EXAM 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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