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FDA 510(k)

STERILE CUSTOM SURGICAL KITS

K-Number: K914244 · 1992-02-24

ApplicantUlti-Med Intl., Inc.
Decision Date1992-02-24
Product CodeKDD
Advisory CommitteeSU
DecisionUnknown

Device Summary

STERILE CUSTOM SURGICAL KITS is the device name listed in this FDA 510(k) record. The listed applicant is Ulti-Med Intl., Inc.. It received FDA 510(k) clearance on 1992-02-24 under 510(k) number K914244. The device is classified under product code KDD. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the STERILE CUSTOM SURGICAL KITS?

STERILE CUSTOM SURGICAL KITS is a medical device that received FDA 510(k) clearance on 1992-02-24. The listed applicant is Ulti-Med Intl., Inc.. The 510(k) number is K914244.

When did STERILE CUSTOM SURGICAL KITS receive FDA 510(k) clearance?

STERILE CUSTOM SURGICAL KITS received FDA 510(k) clearance on 1992-02-24, under 510(k) number K914244.

Who is the listed applicant for STERILE CUSTOM SURGICAL KITS?

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

What is the FDA product code for STERILE CUSTOM SURGICAL KITS?

The FDA product code for STERILE CUSTOM SURGICAL KITS is KDD.

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Other records listing Ulti-Med Intl., 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.

K103011ULTICARE SAFETY INSULIN SYRINGEK923176SURGICAL INSTRUMENT KIT, DISPOSABLEK923175SURGICAL INSTRUMENT KIT, DISPOSABLEK920989SURGICAL INSTRUMENT KIT, DISPOSABLEK922828ULCER WOUND TRAYK914431ABSORBENT FIBER

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Related Devices (Code: KDD)

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.

K072814CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURESCovidienK011514INSTRUMENTS FOR ONE TIME USE - DISPOSABLEKencap , Ltd.K971317NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYSNational Healthcare Mfg. Corp.K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAYDenver Biomaterials, Inc.K936255CUSTOM CV PACKAssociated MedicalK932219SUTURE SET OR LACERATION TRAYS (PACKS)Associated Medical Products Co.

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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