The following data is part of a premarket notification filed by American Surgical Company, Llc with the FDA for American Surgical Company/ Neurosurgical Sponges (brand).
| Device ID | K112598 |
| 510k Number | K112598 |
| Device Name: | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) |
| Classification | Neurosurgical Paddie |
| Applicant | AMERICAN SURGICAL COMPANY, LLC 82 SANDERSON AVENUE Lynn, MA 01902 |
| Contact | Michael Alouane |
| Correspondent | Michael Alouane AMERICAN SURGICAL COMPANY, LLC 82 SANDERSON AVENUE Lynn, MA 01902 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-07 |
| Decision Date | 2013-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30749915002365 | K112598 | 000 |
| 20749915002351 | K112598 | 000 |
| 20749915002375 | K112598 | 000 |
| 20749915002382 | K112598 | 000 |
| 20749915002399 | K112598 | 000 |
| 20749915002405 | K112598 | 000 |
| 20749915002412 | K112598 | 000 |
| 20749915002429 | K112598 | 000 |
| 20749915002436 | K112598 | 000 |
| 20749915002443 | K112598 | 000 |
| 20749915002450 | K112598 | 000 |
| 20749915002344 | K112598 | 000 |