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FDA 510(k)

RECEPTAL SAF-GARD(TM) SYSTEM

K-Number: K885208 · 1989-03-17

ApplicantAbbott Laboratories
Decision Date1989-03-17
Product CodeGCX
Advisory CommitteeHO
DecisionUnknown

Device Summary

RECEPTAL SAF-GARD(TM) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-03-17 under 510(k) number K885208. The device is classified under product code GCX. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the RECEPTAL SAF-GARD(TM) SYSTEM?

RECEPTAL SAF-GARD(TM) SYSTEM is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Abbott Laboratories. The 510(k) number is K885208.

When did RECEPTAL SAF-GARD(TM) SYSTEM receive FDA 510(k) clearance?

RECEPTAL SAF-GARD(TM) SYSTEM received FDA 510(k) clearance on 1989-03-17, under 510(k) number K885208.

Who is the listed applicant for RECEPTAL SAF-GARD(TM) SYSTEM?

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

What is the FDA product code for RECEPTAL SAF-GARD(TM) SYSTEM?

The FDA product code for RECEPTAL SAF-GARD(TM) SYSTEM is GCX.

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Related Devices (Code: GCX)

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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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