The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Montgomery Thyroplasty Implant System.
| Device ID | K972317 |
| 510k Number | K972317 |
| Device Name: | MONTGOMERY THYROPLASTY IMPLANT SYSTEM |
| Classification | System, Vocal Cord Medialization |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Rosina Robinson |
| Correspondent | Rosina Robinson BOSTON MEDICAL PRODUCTS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | MIX |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1997-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 34063107101756 | K972317 | 000 |
| 14063107102537 | K972317 | 000 |
| 14063107102544 | K972317 | 000 |
| 14063107102551 | K972317 | 000 |
| 14063107102568 | K972317 | 000 |
| 14063107102575 | K972317 | 000 |
| 14063107102582 | K972317 | 000 |
| 14063107102599 | K972317 | 000 |
| 14063107102605 | K972317 | 000 |
| 14063107102612 | K972317 | 000 |
| 34063107102623 | K972317 | 000 |
| 34063107102630 | K972317 | 000 |
| 14063107102766 | K972317 | 000 |
| 14063107102841 | K972317 | 000 |
| 14063107102520 | K972317 | 000 |
| 14063107102513 | K972317 | 000 |
| 14063107102506 | K972317 | 000 |
| 34063107101763 | K972317 | 000 |
| 34063107101770 | K972317 | 000 |
| 34063107101787 | K972317 | 000 |
| 34063107101794 | K972317 | 000 |
| 34063107101800 | K972317 | 000 |
| 34063107101817 | K972317 | 000 |
| 34063107101824 | K972317 | 000 |
| 34063107101831 | K972317 | 000 |
| 34063107101848 | K972317 | 000 |
| 34063107101855 | K972317 | 000 |
| 34063107101862 | K972317 | 000 |
| 14063107102483 | K972317 | 000 |
| 14063107102490 | K972317 | 000 |
| EBESMT2001 | K972317 | 000 |
| EBESMT200P1 | K972317 | 000 |
| EBESMT2010 | K972317 | 000 |
| EBESMTF100 | K972317 | 000 |
| EBESMTF110 | K972317 | 000 |
| EBESMTM011 | K972317 | 000 |
| EBESMTM080 | K972317 | 000 |
| EBESMTM090 | K972317 | 000 |
| EBESMTM100 | K972317 | 000 |
| EBESMTM110 | K972317 | 000 |
| EBESMTM120 | K972317 | 000 |
| EBESMTM130 | K972317 | 000 |
| EBESMT2090 | K972317 | 000 |
| EBESMT2100 | K972317 | 000 |
| EBESMT2110 | K972317 | 000 |
| EBESMT2120 | K972317 | 000 |
| EBESMTF090 | K972317 | 000 |
| EBESMTF080 | K972317 | 000 |
| EBESMTF070 | K972317 | 000 |
| EBESMT2020 | K972317 | 000 |
| EBESMT2030 | K972317 | 000 |
| EBESMT2040 | K972317 | 000 |
| EBESMT2050 | K972317 | 000 |
| EBESMT2060 | K972317 | 000 |
| EBESMT2070 | K972317 | 000 |
| EBESMT2080 | K972317 | 000 |
| EBESMT2251 | K972317 | 000 |
| EBESMT3000 | K972317 | 000 |
| EBESMT4000 | K972317 | 000 |
| EBESMTC011 | K972317 | 000 |
| EBESMTF011 | K972317 | 000 |
| EBESMTF060 | K972317 | 000 |
| EBESMT2130 | K972317 | 000 |