REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA

Insufflator, Hysteroscopic

WASHINGTON REGULATORY SERVICES

The following data is part of a premarket notification filed by Washington Regulatory Services with the FDA for Register, A Disposable Hysterography Cupula.

Pre-market Notification Details

• Device ID: K894259
• 510k Number: K894259
• Device Name: REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA
• Classification: Insufflator, Hysteroscopic
• Applicant: WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551
• Contact: Randolph Cooke
• Correspondent: Randolph Cooke; WASHINGTON REGULATORY SERVICES R.D. # 3 BOX 237 WELISEWITZ RD. Ringoes, NJ 08551
• Product Code: HIG
• CFR Regulation Number: 884.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-06-20
• Decision Date: 1990-03-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700111401167	K894259	000
03700111401150	K894259	000
03700111401143	K894259	000
03700111401136	K894259	000
03700111401129	K894259	000
03700111401112	K894259	000
03700111401105	K894259	000
03700111401099	K894259	000