Medical Device Manufacturer · US , Asheville , NC

Envis, Inc.

1 submissions · 1 cleared · Since 1999

Total

Cleared

Denied

Envis, Inc. — FDA 510(k) Submissions

Envis, Inc. has submitted 1 FDA 510(k) premarket notifications since 1999, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Applicator, Ent Drug . Use the specialty filter in the sidebar to narrow results.

1 devices

1–1 of 1

AROMAPATCH

K984345 · LRD Applicator, Ent Drug · Ear, Nose, Throat

Mar 1999 105d

Envis, Inc.

Envis, Inc. — FDA 510(k) Submissions

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