The following data is part of a premarket notification filed by Arrow Intl., Inc. with the FDA for Non-absorbable Silk Suture.
| Device ID | K071111 |
| 510k Number | K071111 |
| Device Name: | NON-ABSORBABLE SILK SUTURE |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Contact | Karl J Nittinger |
| Correspondent | Karl J Nittinger ARROW INTL., INC. 2400 BERNVILLE RD. Reading, PA 19605 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-20 |
| Decision Date | 2007-07-17 |
| Summary: | summary |