The following data is part of a premarket notification filed by Devon Industries, Inc. with the FDA for Birthday Kit (obstetrical Delivery Kit).
| Device ID | K961993 |
| 510k Number | K961993 |
| Device Name: | BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) |
| Classification | Labor And Delivery Kit |
| Applicant | DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 -5084 |
| Contact | George Austria |
| Correspondent | George Austria DEVON INDUSTRIES, INC. 9530 DESOTO AVE. Chatsworth, CA 91311 -5084 |
| Product Code | MLS |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-21 |
| Decision Date | 1996-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884527015535 | K961993 | 000 |
| 10884527015481 | K961993 | 000 |
| 10884527007707 | K961993 | 000 |
| 20884521215013 | K961993 | 000 |