The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Pneumoperitoneum Insufflation Needle.
| Device ID | K021247 |
| 510k Number | K021247 |
| Device Name: | PNEUMOPERITONEUM INSUFFLATION NEEDLE |
| Classification | Insufflator, Laparoscopic |
| Applicant | MECTRA LABS, INC. P.O. BOX 350 Bloomfield, IN 47424 |
| Contact | Charles E Allgood |
| Correspondent | Charles E Allgood MECTRA LABS, INC. P.O. BOX 350 Bloomfield, IN 47424 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-19 |
| Decision Date | 2002-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817984010669 | K021247 | 000 |
| 10817984010652 | K021247 | 000 |