The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Suture Retriever, Sterile Disposable.
| Device ID | K881224 |
| 510k Number | K881224 |
| Device Name: | ACUFEX SUTURE RETRIEVER, STERILE DISPOSABLE |
| Classification | Snare, Surgical |
| Applicant | ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Contact | Richard E Franko |
| Correspondent | Richard E Franko ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Product Code | GAE |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-22 |
| Decision Date | 1988-06-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 23596010025047 | K881224 | 000 |