The following data is part of a premarket notification filed by Apple Medical Corp. with the FDA for Pneumo-matic Insufflation Needle.
| Device ID | K970788 |
| 510k Number | K970788 |
| Device Name: | PNEUMO-MATIC INSUFFLATION NEEDLE |
| Classification | Pneumoperitoneum Needle |
| Applicant | APPLE MEDICAL CORP. 580 MAIN ST. Bolton, MA 01740 |
| Contact | Robert W Schaefer |
| Correspondent | Robert W Schaefer APPLE MEDICAL CORP. 580 MAIN ST. Bolton, MA 01740 |
| Product Code | FHO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20888937003677 | K970788 | 000 |
| 20888937003660 | K970788 | 000 |