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FDA 510(k)

PULSATILE PUMP FOR GONADORELIN ACETATE

K-Number: K893488 · 1989-10-31

ApplicantOrtho Pharmaceutical Corp.
Decision Date1989-10-31
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PULSATILE PUMP FOR GONADORELIN ACETATE is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Pharmaceutical Corp.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K893488. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSATILE PUMP FOR GONADORELIN ACETATE?

PULSATILE PUMP FOR GONADORELIN ACETATE is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Ortho Pharmaceutical Corp.. The 510(k) number is K893488.

When did PULSATILE PUMP FOR GONADORELIN ACETATE receive FDA 510(k) clearance?

PULSATILE PUMP FOR GONADORELIN ACETATE received FDA 510(k) clearance on 1989-10-31, under 510(k) number K893488.

Who is the listed applicant for PULSATILE PUMP FOR GONADORELIN ACETATE?

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

What is the FDA product code for PULSATILE PUMP FOR GONADORELIN ACETATE?

The FDA product code for PULSATILE PUMP FOR GONADORELIN ACETATE is FRN.

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Other records listing Ortho Pharmaceutical Corp. as applicant

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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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