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FDA 510(k)

AMER. PHARMASEAL SILICONIZED LATEX

K-Number: K841544 · 1984-07-09

ApplicantAmerican Pharmaseal Div. Ahsc
Decision Date1984-07-09
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMER. PHARMASEAL SILICONIZED LATEX is the device name listed in this FDA 510(k) record. The listed applicant is American Pharmaseal Div. Ahsc. It received FDA 510(k) clearance on 1984-07-09 under 510(k) number K841544. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. PHARMASEAL SILICONIZED LATEX?

AMER. PHARMASEAL SILICONIZED LATEX is a medical device that received FDA 510(k) clearance on 1984-07-09. The listed applicant is American Pharmaseal Div. Ahsc. The 510(k) number is K841544.

When did AMER. PHARMASEAL SILICONIZED LATEX receive FDA 510(k) clearance?

AMER. PHARMASEAL SILICONIZED LATEX received FDA 510(k) clearance on 1984-07-09, under 510(k) number K841544.

Who is the listed applicant for AMER. PHARMASEAL SILICONIZED LATEX?

The FDA 510(k) record lists American Pharmaseal Div. Ahsc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMER. PHARMASEAL SILICONIZED LATEX?

The FDA product code for AMER. PHARMASEAL SILICONIZED LATEX is KOD.

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Other records listing American Pharmaseal Div. Ahsc as applicant

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Related Devices (Code: KOD)

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.

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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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