The following data is part of a premarket notification filed by Igenics, Inc. with the FDA for Drain/slit Sponge (non-sterile And Sterile).
| Device ID | K963134 |
| 510k Number | K963134 |
| Device Name: | DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) |
| Classification | Gauze/sponge, Internal |
| Applicant | IGENICS, INC. ONE BEACON ST. Boston, MA 02108 |
| Contact | G. Thacher Storm |
| Correspondent | G. Thacher Storm IGENICS, INC. ONE BEACON ST. Boston, MA 02108 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1996-09-06 |
| Summary: | summary |