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510(k) K874615

LASER CANNISTER FILTER by Medical Marketing, Inc. — Product Code HHR

K874615 is an FDA 510(k) premarket notification submitted by Medical Marketing, Inc. for the device "LASER CANNISTER FILTER". The FDA issued a decision of Substantially Equivalent on June 23, 1988. The device falls under product code HHR (Laser, Surgical, Gynecologic), a Class II device regulated under 21 CFR 884.4550. Medical Marketing, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
November 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

Other clearances by Medical Marketing, Inc.

  • K874612 — TITANIUM RODS (June 23, 1988)
  • K874614 — SUCTION AND LAVAGE PROBE (June 23, 1988)
  • K874611 — TITANIUM BACKSTOP WITH SUCTION (June 23, 1988)

Other clearances for product code HHR

  • K881507 — ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES (April 27, 1989)
  • K871875 — MODEL 5050 SURGILASER FOR OB-GYN USE (August 22, 1988)
  • K875314 — GL-35 COLPOSCOPIC LASER SYSTEM (August 5, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
  • K880173 — MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION (March 24, 1988)
  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)
  • K870841 — MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (February 2, 1988)

FDA data resources