ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

CONMED CORP.

The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Aspen Surgical Systems Accessory Electrode.

Pre-market Notification Details

Device IDK943542
510k NumberK943542
Device Name:ASPEN SURGICAL SYSTEMS ACCESSORY ELECTRODE
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant CONMED CORP. 3040 EAST RIVER RD. Dayton,  OH  45439
ContactIra D Duesler
CorrespondentIra D Duesler
CONMED CORP. 3040 EAST RIVER RD. Dayton,  OH  45439
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-22
Decision Date1994-09-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20653405032059 K943542 000
20653405003325 K943542 000
40653405003213 K943542 000
30653405032056 K943542 000
30653405032032 K943542 000
30653405003438 K943542 000
30653405003407 K943542 000
30653405003360 K943542 000
00653405032055 K943542 000
00653405032031 K943542 000
00653405003437 K943542 000
00653405003406 K943542 000
20653405003332 K943542 000
20653405003349 K943542 000
20653405032035 K943542 000
20653405003479 K943542 000
20653405003462 K943542 000
20653405003448 K943542 000
20653405003431 K943542 000
20653405003424 K943542 000
20653405003417 K943542 000
20653405003400 K943542 000
20653405003394 K943542 000
20653405003363 K943542 000
20653405003356 K943542 000
00653405003369 K943542 000

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