The following data is part of a premarket notification filed by Boston Medical Products, Inc. with the FDA for Otosilk.
| Device ID | K952203 |
| 510k Number | K952203 |
| Device Name: | OTOSILK |
| Classification | Dressing, Wound, Occlusive |
| Applicant | BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Contact | Stuart K Montgomery |
| Correspondent | Stuart K Montgomery BOSTON MEDICAL PRODUCTS, INC. 117 FLANDERS RD. Westborough, MA 01581 |
| Product Code | NAD |
| CFR Regulation Number | 878.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-10 |
| Decision Date | 1995-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EBESOT175100 | K952203 | 000 |
| EBESOT166100 | K952203 | 000 |
| 34063107102432 | K952203 | 000 |
| 34063107102425 | K952203 | 000 |