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510(k) K895403

Device
ASPIRETTE ENDOCERVICAL ASPIRATOR
Applicant
UNIMAR, INC.
510(k) number
K895403
Product code
HFC  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-29
Date received
1989-09-07
Regulation
884.1050
Classification name
Aspirator, Endocervical
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ANTHONY HEMMING
Address
475 Danbury Rd. Wilton CT US 06897 06897

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K974032ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATORA & A Medical, Inc.1997-12-22
K960263CERVICAL MUCOUS ASPIRATION CATHETERCook Urological, Inc.1996-08-29
K954903PEDI VAGINAL ASPIRATORCook Urological, Inc.1996-04-29
K954102SELECTMUCUSSelect Medical Systems, Inc.1995-11-21
K902242ENDOCERVICAL ASPIRATORInnovative Medical Products, Inc.1990-10-09
K902032O. B. PACK IVCustomed, Inc.1990-09-28
K902954OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)Permobil AB1990-08-23
K821134DC PACK TMSeamless Hospital Products Co.1982-06-22
K812175ENDOCERVICAL ASPIRATORFertility Instrumentation, Inc.1981-09-21
K801238ACCU-PAP T ZONE SAMPLERRobert Hasselbrack, M.D.1980-08-12

Legacy Summary#

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FDA Review#

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