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FDA 510(k)

SPENCO BREAST FORMS

K-Number: K896533 · 1989-12-13

ApplicantSpenco Medical Corp.
Decision Date1989-12-13
Product CodeKCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPENCO BREAST FORMS is the device name listed in this FDA 510(k) record. The listed applicant is Spenco Medical Corp.. It received FDA 510(k) clearance on 1989-12-13 under 510(k) number K896533. The device is classified under product code KCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPENCO BREAST FORMS?

SPENCO BREAST FORMS is a medical device that received FDA 510(k) clearance on 1989-12-13. The listed applicant is Spenco Medical Corp.. The 510(k) number is K896533.

When did SPENCO BREAST FORMS receive FDA 510(k) clearance?

SPENCO BREAST FORMS received FDA 510(k) clearance on 1989-12-13, under 510(k) number K896533.

Who is the listed applicant for SPENCO BREAST FORMS?

The FDA 510(k) record lists Spenco Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPENCO BREAST FORMS?

The FDA product code for SPENCO BREAST FORMS is KCZ.

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Other records listing Spenco Medical Corp. 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.

K981902SPENCO SILICONE GEL SHEETK9222282ND SKIN STERILE ADHESIVE STRIPK9115502ND SKIN MOIST BURN PADS WITH ALOEK910927SPENCIO SKIN GUARD KITK8948982ND SKIN NON-STICK MOIST BURN PADSK820906SPENCO CRYOPRESS

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Related Devices (Code: KCZ)

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.

K990458STRAUMANN EXTRAORAL IMPLANT SYSTEMStraumann USAK951324MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESISMaxol Limited L.C.K933465COSMETGreat Bay Medical Products, Inc.K932978CALSSIQUE OR MYSTIQUEDekumed, Kunststofftechnik Degler GmbHK932899CLASSIQUEHemispheres Marketing Co. , Ltd.K933668ALMOST U, INC. BREAST PROSTHESISAlmost U., 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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