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510(k) K821134

DC PACK TM by Seamless Hospital Products Co. — Product Code HFC

K821134 is an FDA 510(k) premarket notification submitted by Seamless Hospital Products Co. for the device "DC PACK TM". The FDA issued a decision of Substantially Equivalent on June 22, 1982. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050. Seamless Hospital Products Co. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1982
Date Received
April 20, 1982
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 by Seamless Hospital Products Co.

  • K841769 — INTERMITTENT URETHRAL CATHETER TRAY (August 24, 1984)
  • K823061 — BRUSH, SCRUB, OPERATING ROOM (November 5, 1982)
  • K820490 — IV START TRAY (March 16, 1982)
  • K781127 — CONNECTING TUBE, CONDUCTIVE, SURG. (September 20, 1978)

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)
  • K812175 — ENDOCERVICAL ASPIRATOR (September 21, 1981)
  • K801238 — ACCU-PAP T ZONE SAMPLER (August 12, 1980)

FDA data resources