510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K853037Substantially Equivalent

Dr. Hessel's Vacuum Extractor

Medic Group of Scandinavia, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853037 is the FDA 510(k) clearance record for DR. HESSEL'S VACUUM EXTRACTOR, cleared for Medic Group of Scandinavia, Inc. on . FDA records list one 510(k) clearance for Medic Group of Scandinavia, Inc. As of , FDA records show no recalls naming K853037.

Clearance record

Decision date
Received
(19 days to decision)
Review panel
Unknown
Applicant
Medic Group of Scandinavia, Inc. Federal Bar Bldg., Washington DC
Third party review
No