Atlas FDA

ECONOM

FDA 510(k) clearance K925754 · decided 1993-10-08

Clearance details

K-number
K925754
Device name
ECONOM
Applicant
Rudolf Riester GmbH & Co. KG
Decision
Substantially Equivalent
Date received
1992-11-13
Decision date
1993-10-08
Days to decision
329 days
Clearance type
Traditional
Product code
EPY
Device class
1
Regulation number
878.1800
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
D-72417 Jungingen, DE
Third-party review
No
Expedited review
No

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RecordFirmDate
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EAR AND NOSE SPECULA (K791123)Xomed, Inc.1979-07-10
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THIN-BLADED NASAL SPECULUM (K772385)Edward Weck, Inc.1978-01-17
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Recalls involving this device

No recalls on record reference this clearance.