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510(k) K801238

ACCU-PAP T ZONE SAMPLER by Robert Hasselbrack, M.D. — Product Code HFC

K801238 is an FDA 510(k) premarket notification submitted by Robert Hasselbrack, M.D. for the device "ACCU-PAP T ZONE SAMPLER". The FDA issued a decision of Substantially Equivalent on August 12, 1980. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1980
Date Received
May 27, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspirator, Endocervical
Device Class
Class II
Regulation Number
884.1050
Review Panel
OB
Submission Type

Other clearances for product code HFC

  • K974032 — ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY (December 22, 1997)
  • K960263 — CERVICAL MUCOUS ASPIRATION CATHETER (August 29, 1996)
  • K954903 — PEDI VAGINAL ASPIRATOR (April 29, 1996)
  • K954102 — SELECTMUCUS (November 21, 1995)
  • K902242 — ENDOCERVICAL ASPIRATOR (October 9, 1990)
  • K902032 — O. B. PACK IV (September 28, 1990)
  • K902954 — OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) (August 23, 1990)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K821134 — DC PACK TM (June 22, 1982)
  • K812175 — ENDOCERVICAL ASPIRATOR (September 21, 1981)

FDA data resources