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FDA 510(k)

OVAL SHAPES

K-Number: K973385 · 1997-12-05

ApplicantTechnical Products, Inc.
Decision Date1997-12-05
Product CodeHXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OVAL SHAPES is the device name listed in this FDA 510(k) record. The listed applicant is Technical Products, Inc.. It received FDA 510(k) clearance on 1997-12-05 under 510(k) number K973385. The device is classified under product code HXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVAL SHAPES?

OVAL SHAPES is a medical device that received FDA 510(k) clearance on 1997-12-05. The listed applicant is Technical Products, Inc.. The 510(k) number is K973385.

When did OVAL SHAPES receive FDA 510(k) clearance?

OVAL SHAPES received FDA 510(k) clearance on 1997-12-05, under 510(k) number K973385.

Who is the listed applicant for OVAL SHAPES?

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

What is the FDA product code for OVAL SHAPES?

The FDA product code for OVAL SHAPES is HXA.

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Other records listing Technical 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.

K013321SILICONE TRACHEAL T-TUBESK973166DOW CORNING SILASTIC ELASTOMER Q7-4750K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAK971613SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBINGK954116SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP

Related Devices (Code: HXA)

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.

K243477Universal Tendon SpacerAskorn MedicalK000019SINGLE SIZE TENDON SPACERMedist InternationalK964359AVANTA ORTHOPAEDICS TENDON SPACERAvanta Orthopaedics, Inc.K930125PHOENIX BONE SCREWS PBS-TYPE SERIESPhoenix Bioengineering, Inc.K872284H-H HUNTER ACTIVE TENDON IMPLANT PCHolter-Hausner Intl.K872285H-H HUNTER ACTIVE TENDON IMPLANT DCHolter-Hausner Intl.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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