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 |