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FDA 510(k)

DELTA-ROL

K-Number: K790340 · 1979-04-12

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1979-04-12
Product CodeGCO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DELTA-ROL is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1979-04-12 under 510(k) number K790340. The device is classified under product code GCO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DELTA-ROL?

DELTA-ROL is a medical device that received FDA 510(k) clearance on 1979-04-12. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K790340.

When did DELTA-ROL receive FDA 510(k) clearance?

DELTA-ROL received FDA 510(k) clearance on 1979-04-12, under 510(k) number K790340.

Who is the listed applicant for DELTA-ROL?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DELTA-ROL?

The FDA product code for DELTA-ROL is GCO.

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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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