The following data is part of a premarket notification filed by Mani, Inc. with the FDA for Mani Needle & Suture Pack (pga Absorbable).
| Device ID | K053636 |
| 510k Number | K053636 |
| Device Name: | MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | MANI, INC. 1301K STREET, N.W. SUITE 1100 - EAST TOWER Washington, DC 20005 -3373 |
| Contact | David J Bloch |
| Correspondent | David J Bloch MANI, INC. 1301K STREET, N.W. SUITE 1100 - EAST TOWER Washington, DC 20005 -3373 |
| Product Code | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-29 |
| Decision Date | 2006-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546951525514 | K053636 | 000 |
| 14546951403833 | K053636 | 000 |
| 14546951403802 | K053636 | 000 |
| 14546951403666 | K053636 | 000 |
| 04546951403201 | K053636 | 000 |
| 04546951403195 | K053636 | 000 |
| 04546951403188 | K053636 | 000 |
| 04546951403171 | K053636 | 000 |
| 04546951403164 | K053636 | 000 |
| 14546951404366 | K053636 | 000 |
| 04546951525422 | K053636 | 000 |
| 04546951525507 | K053636 | 000 |
| 04546951525491 | K053636 | 000 |
| 04546951525484 | K053636 | 000 |
| 04546951525477 | K053636 | 000 |
| 04546951525460 | K053636 | 000 |
| 04546951525453 | K053636 | 000 |
| 04546951525446 | K053636 | 000 |
| 04546951525439 | K053636 | 000 |
| 04546951403140 | K053636 | 000 |