The following data is part of a premarket notification filed by Mediscope Manufacturing, Inc. with the FDA for Mediscope Compressiopn Staple And Accessories.
| Device ID | K102387 |
| 510k Number | K102387 |
| Device Name: | MEDISCOPE COMPRESSIOPN STAPLE AND ACCESSORIES |
| Classification | Staple, Fixation, Bone |
| Applicant | MEDISCOPE MANUFACTURING, INC. 8282 SHADOW WOOD BLVD Pompano Beach, FL 33069 |
| Contact | Diane Sudduth Ms, Dvm, Mph |
| Correspondent | Diane Sudduth Ms, Dvm, Mph MEDISCOPE MANUFACTURING, INC. 8282 SHADOW WOOD BLVD Pompano Beach, FL 33069 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-23 |
| Decision Date | 2011-10-24 |
| Summary: | summary |