PMA P870080S001

Device: HULKA CLIP FOR TUBAL OCCLUSION
Applicant: Richard Wolf Medical Instruments Corp.
PMA number: P870080
Supplement: S001
Product code: KNH
Decision date: 1998-03-12
Classification: Laparoscopic Contraceptive Tubal Occlusion Device
Generic name: Laparoscopic contraceptive tubal occlusion device
Approval order statement: Approval for the instruction manual "Hulka Clips for Hulka Clip Applicators" - E36 to be included with each box of clips sold.

Current openFDA PMA Record#

Device: HULKA CLIP FOR TUBAL OCCLUSION
Applicant: Richard Wolf Medical Instruments Corp.
PMA number: P870080
Supplement: S001
Product code: KNH
Generic name: Laparoscopic contraceptive tubal occlusion device
Decision date: 1998-03-12
Decision code: APPR
Date received: 1998-01-09
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the instruction manual "Hulka Clips for Hulka Clip Applicators" - E36 to be included with each box of clips sold.