The following data is part of a premarket notification filed by Apple Medical Corp. with the FDA for Apple Medical Mobius Elastic Retractor.
| Device ID | K014005 |
| 510k Number | K014005 |
| Device Name: | APPLE MEDICAL MOBIUS ELASTIC RETRACTOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | APPLE MEDICAL CORP. 28 LORD RD., UNIT 135 Marlboro, MA 01752 |
| Contact | John C Pulford |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-12-05 |
| Decision Date | 2002-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003806 | K014005 | 000 |
| 20888937003790 | K014005 | 000 |
| 20888937003783 | K014005 | 000 |