FDA 510(k)

SWIN'S S-77 MEDIUM, PRODUCTS S2513

K-Number: K851605 · 1985-05-15

Decision Date1985-05-15

Product CodeKIT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

SWIN'S S-77 MEDIUM, PRODUCTS S2513 is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1985-05-15 under 510(k) number K851605. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWIN'S S-77 MEDIUM, PRODUCTS S2513?

SWIN'S S-77 MEDIUM, PRODUCTS S2513 is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Sigma Chemical Co.. The 510(k) number is K851605.

When did SWIN'S S-77 MEDIUM, PRODUCTS S2513 receive FDA 510(k) clearance?

SWIN'S S-77 MEDIUM, PRODUCTS S2513 received FDA 510(k) clearance on 1985-05-15, under 510(k) number K851605.

Who is the listed applicant for SWIN'S S-77 MEDIUM, PRODUCTS S2513?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SWIN'S S-77 MEDIUM, PRODUCTS S2513?

The FDA product code for SWIN'S S-77 MEDIUM, PRODUCTS S2513 is KIT.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: KIT)

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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.