The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Biodegradable Surgical Staple.
| Device ID | K910723 |
| 510k Number | K910723 |
| Device Name: | BIODEGRADABLE SURGICAL STAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | INSTRUMENT MAKAR, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INSTRUMENT MAKAR, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-20 |
| Decision Date | 1991-03-12 |