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FDA 510(k)

SUTURE REMOVAL TRAYS

K-Number: K943090 · 1994-08-22

ApplicantSterile Concepts, Inc.
Decision Date1994-08-22
Product CodeFRG
Advisory CommitteeHO
DecisionUnknown

Device Summary

SUTURE REMOVAL TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Concepts, Inc.. It received FDA 510(k) clearance on 1994-08-22 under 510(k) number K943090. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the SUTURE REMOVAL TRAYS?

SUTURE REMOVAL TRAYS is a medical device that received FDA 510(k) clearance on 1994-08-22. The listed applicant is Sterile Concepts, Inc.. The 510(k) number is K943090.

When did SUTURE REMOVAL TRAYS receive FDA 510(k) clearance?

SUTURE REMOVAL TRAYS received FDA 510(k) clearance on 1994-08-22, under 510(k) number K943090.

Who is the listed applicant for SUTURE REMOVAL TRAYS?

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

What is the FDA product code for SUTURE REMOVAL TRAYS?

The FDA product code for SUTURE REMOVAL TRAYS is FRG.

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Other records listing Sterile Concepts, Inc. as applicant

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K951231ORTHOPEDIC PACKSK951081OB/GYN PACKSK952539RADIOLOGY PACKSK951478GENERAL AND PLASTIC SURGERY PACKSK944139DENTAL HYGIENE TRAYK943047IV START KITS

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Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

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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