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FDA 510(k)

DALE I.V. IDENTIFIER; PRODUCT #1125

K-Number: K894586 · 1989-08-15

ApplicantDale Medical Products, Inc.
Decision Date1989-08-15
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DALE I.V. IDENTIFIER; PRODUCT #1125 is the device name listed in this FDA 510(k) record. The listed applicant is Dale Medical Products, Inc.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K894586. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DALE I.V. IDENTIFIER; PRODUCT #1125?

DALE I.V. IDENTIFIER; PRODUCT #1125 is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Dale Medical Products, Inc.. The 510(k) number is K894586.

When did DALE I.V. IDENTIFIER; PRODUCT #1125 receive FDA 510(k) clearance?

DALE I.V. IDENTIFIER; PRODUCT #1125 received FDA 510(k) clearance on 1989-08-15, under 510(k) number K894586.

Who is the listed applicant for DALE I.V. IDENTIFIER; PRODUCT #1125?

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

What is the FDA product code for DALE I.V. IDENTIFIER; PRODUCT #1125?

The FDA product code for DALE I.V. IDENTIFIER; PRODUCT #1125 is KMK.

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Other records listing Dale Medical Products, 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.

K082241THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751K994300NASOGASTRIC TUBE HOLDER, MODEL 160K964399DALE ENDOTRACHEAL TUBE HOLDER 270/280K961693DALE GASTROSTOMY TUBE HOLDERK951491DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABSK914245DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)

View all 13 devices →

Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, 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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