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FDA 510(k)

PROTECTO-SHIELD

K-Number: K881913 · 1988-07-08

ApplicantSyntech Mfg. Services
Decision Date1988-07-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PROTECTO-SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Syntech Mfg. Services. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K881913. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECTO-SHIELD?

PROTECTO-SHIELD is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Syntech Mfg. Services. The 510(k) number is K881913.

When did PROTECTO-SHIELD receive FDA 510(k) clearance?

PROTECTO-SHIELD received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881913.

Who is the listed applicant for PROTECTO-SHIELD?

The FDA 510(k) record lists Syntech Mfg. Services as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROTECTO-SHIELD?

The FDA product code for PROTECTO-SHIELD is FXX.

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Related Devices (Code: FXX)

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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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