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FDA 510(k)

CIRCUMCISION TRAY, CAT. NO. 70340

K-Number: K974286 · 1997-12-12

ApplicantTrinity Laboratories, Inc.
Decision Date1997-12-12
Product CodeHFX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CIRCUMCISION TRAY, CAT. NO. 70340 is the device name listed in this FDA 510(k) record. The listed applicant is Trinity Laboratories, Inc.. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K974286. The device is classified under product code HFX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIRCUMCISION TRAY, CAT. NO. 70340?

CIRCUMCISION TRAY, CAT. NO. 70340 is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Trinity Laboratories, Inc.. The 510(k) number is K974286.

When did CIRCUMCISION TRAY, CAT. NO. 70340 receive FDA 510(k) clearance?

CIRCUMCISION TRAY, CAT. NO. 70340 received FDA 510(k) clearance on 1997-12-12, under 510(k) number K974286.

Who is the listed applicant for CIRCUMCISION TRAY, CAT. NO. 70340?

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

What is the FDA product code for CIRCUMCISION TRAY, CAT. NO. 70340?

The FDA product code for CIRCUMCISION TRAY, CAT. NO. 70340 is HFX.

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Other records listing Trinity Laboratories, 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.

K981441HEART CATH TRAY, STERILE, DISPOSABLEK974238DENTAL TRAY, STERILE, DISPOSABLEK972160CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TESTK970722EYE TRAYK965201O.R. SCRUB PREP TRAY, STERILE, DISPOSABLEK964921BASIC BIOPSY TRAY. DISPOSABLE, STERILE

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Related Devices (Code: HFX)

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.

K251687Konig Bell Circumcision ClampMedline Industries, LPK221356Wee BellWee MedicalK212911Konig Mogen ClampMedline Industries, Inc.K131373SHANGRINGWuhu Snnda Medical Treatment Appliance TechnologyK121789SHANGRINGWuhu Snna Medical Treatment Appliance Technology CK103695PREPEX SYSTEMCirc Medtech

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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