The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Soft Tissue Expander.
| Device ID | K923381 |
| 510k Number | K923381 |
| Device Name: | SOFT TISSUE EXPANDER |
| Classification | Passer |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Susan Goldstein-falk |
| Correspondent | Susan Goldstein-falk ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HWQ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-09 |
| Decision Date | 1993-05-05 |