The following data is part of a premarket notification filed by Apple Medical Corp. with the FDA for Apple Medical/ob Mobius Elastic Retractor.
| Device ID | K050256 |
| 510k Number | K050256 |
| Device Name: | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR |
| Classification | Retractor |
| Applicant | APPLE MEDICAL CORP. 75 FEDERAL STREET, 9TH FL Boston, MA 02110 |
| Contact | James Delaney |
| Correspondent | James Delaney APPLE MEDICAL CORP. 75 FEDERAL STREET, 9TH FL Boston, MA 02110 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-03 |
| Decision Date | 2005-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003820 | K050256 | 000 |
| 20888937003813 | K050256 | 000 |