The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Suretac Polyglyconate Absorbable Fixation Device.
| Device ID | K911837 |
| 510k Number | K911837 |
| Device Name: | SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE |
| Classification | Staple, Fixation, Bone |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Richard E Franko |
| Correspondent | Richard E Franko ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-25 |
| Decision Date | 1991-11-15 |