PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT

Prosthesis, Partial Ossicular Replacement

Grace Medical, Inc.

The following data is part of a premarket notification filed by Grace Medical, Inc. with the FDA for Partial/total/porous Polyethylene Ossicular Replacement.

Pre-market Notification Details

• Device ID: K972815
• 510k Number: K972815
• Device Name: PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
• Classification: Prosthesis, Partial Ossicular Replacement
• Applicant: Grace Medical, Inc. 7715 HWY. 70, SUITE 109 Bartlett, TN 38133
• Contact: Anthony D Prescott
• Correspondent: Anthony D Prescott; Grace Medical, Inc. 7715 HWY. 70, SUITE 109 Bartlett, TN 38133
• Product Code: ETB
• CFR Regulation Number: 874.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-28
• Decision Date: 1997-10-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00844505008143	K972815	000
00844505000376	K972815	000
00844505000369	K972815	000
00844505000352	K972815	000
00844505000345	K972815	000
00844505000338	K972815	000
00844505000321	K972815	000
00844505000314	K972815	000
00844505000307	K972815	000
00844505000291	K972815	000
00844505000284	K972815	000
00844505000277	K972815	000
00844505000260	K972815	000
00844505000253	K972815	000
00844505000246	K972815	000
00844505000239	K972815	000
00844505000383	K972815	000
00844505000390	K972815	000
00844505008068	K972815	000
00844505007184	K972815	000
00844505006477	K972815	000
00844505006460	K972815	000
00844505006453	K972815	000
00844505006446	K972815	000
00844505006033	K972815	000
00844505006002	K972815	000
00844505002226	K972815	000
00844505000451	K972815	000
00844505000444	K972815	000
00844505000437	K972815	000
00844505000420	K972815	000
00844505000413	K972815	000
00844505000406	K972815	000
00844505000222	K972815	000