The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Nexus Suture.
| Device ID | K151009 |
| 510k Number | K151009 |
| Device Name: | Nexus Suture |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL COMPANY INC. 2645 MATHESON BLVD. EAST Mississauga, CA L4w 5s4 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447000501 | K151009 | 000 |
| 07540299000112 | K151009 | 000 |
| 07540299000105 | K151009 | 000 |
| 07540299000099 | K151009 | 000 |
| 07540299000082 | K151009 | 000 |
| 07540299000075 | K151009 | 000 |
| 17540299000065 | K151009 | 000 |
| 17540299000058 | K151009 | 000 |
| 17540299000041 | K151009 | 000 |
| 17540299000034 | K151009 | 000 |
| 17540299000027 | K151009 | 000 |
| 07540299000129 | K151009 | 000 |
| 10685447000393 | K151009 | 000 |
| 10685447000492 | K151009 | 000 |
| 00685447000488 | K151009 | 000 |
| 10685447000478 | K151009 | 000 |
| 00685447000464 | K151009 | 000 |
| 10685447000454 | K151009 | 000 |
| 00685447000440 | K151009 | 000 |
| 10685447000430 | K151009 | 000 |
| 00685447000426 | K151009 | 000 |
| 10685447000416 | K151009 | 000 |
| 00685447000402 | K151009 | 000 |
| 07540299000013 | K151009 | 000 |