The following data is part of a premarket notification filed by Mani, Inc. with the FDA for Mani Needle & Suture Pack.
| Device ID | K050150 |
| 510k Number | K050150 |
| Device Name: | MANI NEEDLE & SUTURE PACK |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | MANI, INC. 1301 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | David J Bloch |
| Correspondent | David J Bloch MANI, INC. 1301 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-24 |
| Decision Date | 2005-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546951500399 | K050150 | 000 |
| 04546951401436 | K050150 | 000 |
| 14546951401426 | K050150 | 000 |
| 14546951400856 | K050150 | 000 |
| 14546951400764 | K050150 | 000 |
| 14546951400757 | K050150 | 000 |
| 04546951400743 | K050150 | 000 |
| 04546951400736 | K050150 | 000 |
| 14546951400726 | K050150 | 000 |
| 04546951400705 | K050150 | 000 |
| 04546951401917 | K050150 | 000 |
| 04546951402181 | K050150 | 000 |
| 04546951500382 | K050150 | 000 |
| 04546951500337 | K050150 | 000 |
| 04546951402839 | K050150 | 000 |
| 04546951402815 | K050150 | 000 |
| 04546951402792 | K050150 | 000 |
| 04546951402785 | K050150 | 000 |
| 14546951402676 | K050150 | 000 |
| 14546951402669 | K050150 | 000 |
| 04546951402655 | K050150 | 000 |
| 04546951400538 | K050150 | 000 |