ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE

Device, Anti-snoring

FRANTZ DESIGN, INC.

The following data is part of a premarket notification filed by Frantz Design, Inc. with the FDA for Elastic Mandibular Advancement (ema) Appliance.

Pre-market Notification Details

• Device ID: K971794
• 510k Number: K971794
• Device Name: ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
• Classification: Device, Anti-snoring
• Applicant: FRANTZ DESIGN, INC. 400 MEDICAL CENTER, #209 Webster, TX 77598
• Contact: Donald Frantz
• Correspondent: Donald Frantz; FRANTZ DESIGN, INC. 400 MEDICAL CENTER, #209 Webster, TX 77598
• Product Code: LRK
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-05-15
• Decision Date: 1997-09-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842326100473	K971794	000
00842326100329	K971794	000
00842326100312	K971794	000
00842326100305	K971794	000
00842326100282	K971794	000
00842326100275	K971794	000
00842326100268	K971794	000
00842326100251	K971794	000
00842326100244	K971794	000
00842326100237	K971794	000
00842326100220	K971794	000
00842326100336	K971794	000
00842326100343	K971794	000
00842326100350	K971794	000
00842326100466	K971794	000
00842326100459	K971794	000
00842326100442	K971794	000
00842326100435	K971794	000
00842326100428	K971794	000
00842326100411	K971794	000
00842326100404	K971794	000
00842326100381	K971794	000
00842326100374	K971794	000
00842326100367	K971794	000
00842326100213	K971794	000
00842326100206	K971794	000
00842326100046	K971794	000
00842326100039	K971794	000
00842326100022	K971794	000
00842326100015	K971794	000
00842326100008	K971794	000
00842326101159	K971794	000
00842326101142	K971794	000
00842326101180	K971794	000
00842326101173	K971794	000
00842326101166	K971794	000
00842326100053	K971794	000
00842326100060	K971794	000
00842326100077	K971794	000
00842326100183	K971794	000
00842326100176	K971794	000
00842326100169	K971794	000
00842326100152	K971794	000
00842326100145	K971794	000
00842326100138	K971794	000
00842326100121	K971794	000
00842326100114	K971794	000
00842326100107	K971794	000
00842326100084	K971794	000
00842326101197	K971794	000
D745EMA0	K971794	000
90842326100964	K971794	000
90842326100957	K971794	000
90842326100940	K971794	000
90842326100933	K971794	000
90842326100926	K971794	000
90842326100919	K971794	000
90842326100902	K971794	000
90842326100889	K971794	000
90842326100872	K971794	000
90842326100865	K971794	000
90842326100971	K971794	000
90842326100988	K971794	000
90842326101008	K971794	000
90842326101114	K971794	000
90842326101107	K971794	000
90842326101084	K971794	000
90842326101077	K971794	000
90842326101060	K971794	000
90842326101053	K971794	000
90842326101046	K971794	000
90842326101039	K971794	000
90842326101022	K971794	000
90842326101015	K971794	000
90842326100858	K971794	000
90842326100841	K971794	000
00842326100589	K971794	000
00842326100572	K971794	000
00842326100565	K971794	000
00842326100558	K971794	000
00842326100541	K971794	000
00842326100534	K971794	000
00842326100527	K971794	000
00842326100510	K971794	000
00842326100503	K971794	000
00842326100497	K971794	000
90842326100704	K971794	000
90842326100711	K971794	000
90842326100728	K971794	000
90842326100834	K971794	000
90842326100827	K971794	000
90842326100810	K971794	000
90842326100803	K971794	000
90842326100780	K971794	000
90842326100773	K971794	000
90842326100766	K971794	000
90842326100759	K971794	000
90842326100742	K971794	000
90842326100735	K971794	000
00842326100480	K971794	000