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FDA 510(k)

SILASTIC II MAMMARY IMPLANT

K-Number: K801175 · 1980-12-18

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1980-12-18
Product Code
DecisionSubstantially Equivalent

Device Summary

SILASTIC II MAMMARY IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K801175. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILASTIC II MAMMARY IMPLANT?

SILASTIC II MAMMARY IMPLANT is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K801175.

When did SILASTIC II MAMMARY IMPLANT receive FDA 510(k) clearance?

SILASTIC II MAMMARY IMPLANT received FDA 510(k) clearance on 1980-12-18, under 510(k) number K801175.

Who is the listed applicant for SILASTIC II MAMMARY IMPLANT?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Dow Corning Corp. Healthcare Industries Materials 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.

K853186SILASTIC INFLATABLE BONE PLUG H.P.K844637WHITESIDE ACRYLIC CEMENT SPACER SLEEVEK850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETK843995TF-II HIP PROSTHESISK842559WHITESIDE ORTHOLOC TOTAL HIP FEMORALK840357SSA HIP PROSTHESIS

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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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