The following data is part of a premarket notification filed by Mectra Labs, Inc. with the FDA for Insufflator, Laparoscopic.
| Device ID | K920959 |
| 510k Number | K920959 |
| Device Name: | INSUFFLATOR, LAPAROSCOPIC |
| Classification | Insufflator, Laparoscopic |
| Applicant | MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY Bloomfield, IN 47424 |
| Contact | Elizabeth Feldman |
| Correspondent | Elizabeth Feldman MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY 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 | 1992-02-25 |
| Decision Date | 1992-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817984011185 | K920959 | 000 |
| 10817984010096 | K920959 | 000 |
| 10817984010102 | K920959 | 000 |
| 10817984010119 | K920959 | 000 |
| 10817984010126 | K920959 | 000 |
| 10817984010140 | K920959 | 000 |
| 10817984010157 | K920959 | 000 |
| 10817984010164 | K920959 | 000 |
| 10817984010171 | K920959 | 000 |
| 10817984010928 | K920959 | 000 |
| 10817984010973 | K920959 | 000 |
| 10817984010980 | K920959 | 000 |
| 10817984011062 | K920959 | 000 |
| 10817984011079 | K920959 | 000 |
| 10817984011178 | K920959 | 000 |
| 10817984010089 | K920959 | 000 |